Contract Laboratory has received the following incoming Laboratory Test Requests which need to be fulfilled! These Laboratory Test Requests are received from a variety of sources ranging from start-up companies to large, multinational Fortune 500 corporations, international organizations, well-respected universities and government agencies that are actively seeking Independent, Third-Party Medical Devices Laboratories to perform their Medical Devices Testing, Analysis, Assays, Product Development, Scientific Research Experiments, Inspections, Certifications, and Engineering Projects. If you are a Medical Devices laboratory that would like more information on these Medical Devices projects, please visit Register Laboratories or call toll free 1-855-377-6821.
Packaging Laboratory needed for Medical Device Package Design Qualification Testing of a UN 4G Fiberboard Box With 47 x 40 x 1.5-mil poly Red Bag with twist tie and knotted closure This package is not certified for shipment by air. Box Information: 32# ECT (38-26C-38) / D/C Special Design style / ?C? flute / glued joint / Extended design carrying handles / Auto bottom / interlocking top Part Number: 17 x 14 x 19 Outer Dimensions: 18? x 15 ¼? x 20 1/8? (24 ¼?) Inner Dimensions: 17 ¾? x 15? x 19 5/8? Manufacturers Joint: Glued with a 1.25? inside tapered flap Tare Weight: Box: 1.8 lbs. Basis Weights
FDA GLP ISO-17025 bioanalytical laboratory needed for characterization of collagen scaffold medical device including amino acid analysis, quantification of Collagen I, DNA, GAG and lipids, protein assay, and trypsin resistance. residue analysis, hydroxyproline determination,
Medical device company needs clinical product safety laboratory for in-vivo, in-vitro and microbiology testing of disposable feminine pads including:
Surface device testing with just contact to the skin or breached/compromised surface (due to labial contact). We will do a limited exposure (less than 24 hours) testing.
Microbiology testing as pads release oxygen and slightly acidify the pH within the pad once blood reaches our patented powder. We want to see if it has any effect on microbes.
Measure the pH after blood has entered the pad to see how the pH is affected after blood has entered.
Amount of oxygen released per pad, the amount of CO2 absorbed per pad and the amount of humidity absorbed per pad?
URGENT TESTING FDA GMP Medical device preclinical laboratory needed for product safety and toxicity studies of a plastic dental aligner. Risk Assessment in regards to human exposure (oral, dermal, inhalation) is requested for a dental aligner and support-removal media. The dental plastic aligner is thermoformed onto a 3D printed mold that was previously soaked in our support-removal media.
Medical Device preclinical contract research organization CRO needed for insulin characterization with or without infusion through medical device: (1) High molecular weight proteins (insulin aggregates), (2) Preservative content (m-cresol), (3) Impurities, (4) Bioidentity (blood glucose response in rabbits), (5) Zinc content and (6) insulin recovery.
Medical devices laboratory needed for ISO Testing of medical breathing tubing to ISO 5367 Annex A, Annex C, Annex D, Annex E, Annex F, testing of tubing: ANNEX A: RESISTANCE TO AIR FLOW ANNEX D: LEAKAGE ANNEX E: INCREASE IN FLOW RESISTANCE WITH BENDING ANNEX F: COMPLIANCE ANNEX C: SECURITY OF ATTACHMENT OF ADAPTER TO BREATHING TUBE
Medical Device laboratory needed for ASTM and ISO product safety testing for evaluation of medical devices including toxicology, packaging and microbiology testing:
ASTM D7661-10, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms for compliance with latex and polyisoprene condoms.
ISO 10993-5 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological Evaluation of Medical Devices-Part 10: Tests for irritation and skin sensitization
ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for systemic toxicity
United States Pharmacopeia, National Formulary General Chapter <88>: Biological Reactivity Tests, In Vivo
USP <51> Antimicrobial Effectiveness Testing
USP <61> Microbiological Examination of Nonst
Materials laboratory needed for IEST and ASTM Clean Room Gloves Testing: 1 Tensile Strength ASTM D412 2 Ultimate Elongation ASTM D412 3 Surface Resistivity @50%RH ESD/EOS S11.11 4 MVTR 5 Shedding and extractables - IEST RP-CC005.4 LPC ? 0.5 ?m, Cl?, NO3-, Zn2+, SO42+, Na?, K?, Ca2+, Al3+, Fe3+, Cu2+, Total NVR in IPA
FDA GMP medical device laboratory needed for preclinical product safety testing: biocompatibility (10993) sensitization, cytotoxicity, irritation and and electrical(60601) testing for class II medical device with focus on FDA application. We need GPMS sensitization, cytotoxicity, muscosal irritation tests conducted. For 60601, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1 reports are needed.
FDA GMP Laboratory needed for FDA Nebulizer Aerosol Testing: to FDA 784 Guidance: 27 aerosol tests (1 nebulizer model, 1 flow rate, 3 sample devices [random samples], 3 drugs [albuterol sulfate, ipratropium bromide, cromolyn sodium]), 3 tests per sample per drug [3 samples x 3 drugs x 3 tests per sample per drug = 27 tests]. Cascade impactor run at continuous 28 l/min to simulate adult conditions. Predicate Nebulizer Testing: 9 aerosol tests (1 nebulizer model, 3 samples, 3 drugs [albuterol sulfate, ipratropium bromide, cromolyn sodium]), 1 test per sample per drug [1 model x 3 samples per model x 3 drugs = 9 tests]. Cascade impactor run at continuous 28 l/min. Testing report to include reporting on MMAD, GSD, Total Dose, Respirable Fraction (% 1-5 microns), Respirable Dose (ug 1-5 microns), Coarse Particle Dose ( > 4.7 microns), Fine
URGENT TESTING Large Medical Device Company needs Microbiology laboratory for EP/USP Ethylene Oxide sterilization validation testing for 4 different products as per ISO 11737-2. Validate the Ethylene Oxide sterilization process, EP/USP including validation of test methods (B&F)
Regenerative Medicine Company needs FDA GMP or GMP compliant bioanalytical laboratory for characterization studies on the residual antibiotic (aminoglycoside) content of various tissue products under development.Previous successful work in validating analytical methods per USP Q2(R1) a must.
Medical Device Product Safety Laboratory needed for all biological testing for latex based medical devices with colorants needed for CE mark, FDA, ISO 13485 and Japanese biological safety requirements. Our products contact mucosal surfaces for weeks. May also need microbiology testing for sterilization.
Veterinary medicine laboratory needed for performance testing of diagnostic monitoring device that measures heart function, respiration rate, and continuous blood pressure against blood pressure machines (arterial catheters, doppler methods, and tail cuffs) for accuracy of values. It will need to be tested on both standing horses and horses under general anesthesia. Approximately 20-30 horses will need to be used.
Materials laboratory needed for surgical gowns testing - NFPA Standards - Standards for the use of Inhalation Anesthetics.
- ASTM 1670, Standard Test Method for Resistance of Protective Clothing Materials to Synthetic Blood.
- ASTM 1671 Test Method for Resistance of Protective Clothing Materials to Penetration by Bloodborne Pathogens Using Viral Penetration as a Test System.
- ANSI/AAMI PB70:2012, Liquid Barrier Perfrmance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
- ASTM F2407-06, Standard Specification for Surgical Gowns Intended for Use in HEalthcare Facilities.
- ASTM F1670-08/F1670M-08, Standard Tests Method for Resistance of Materials Used in Protective Clothing to penetration by synthetic blood.
- ASTM F1671/ F1671M -13, Standard Test Method for Resistance of
Laboratory needed for transportation test for the new packaging box according to ASTM D4169-09 as per below: Please help to quote the test as below, Distribution Cycle 13, Assurance Level III. Test sequence as below: 1. Temperature and Humidity Conditioning 2. Schedule A: Handling 3. Schedule C: Vehicle Stacking 4. Schedule F: Loose-load vibration 5. Schedule I: Low Pressure 6. Schedule E: Vehicle Vibration 7. Schedule J: Concentrated Impact 8. Schedule A: Handling
Medical Device Company needs medical technology laboratory for packaging/ product /development of developing a disposable medical cable assembly that will require sterilization. ABS plastic housing for connectors Silicone vs PVC for cable assembly I have questions about cost, materials, packaging and logistics.
Medical Device Microbiology Laboratory needed for disinfection and cleaning efficacy testing for needleless IV connector. to ASTM-E-1837 Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test) AND/OR ASTM-E-2314 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test) needs to be performed. 6 cases need to performed in triplicate for each standard. The device being evaluated is a needleless IV connector.
Very Experienced, FDA certified Preclinical Contract Research Organization needed for in vivo preclinical studies for 2 phase subset of FDA biocompatibility testing of eye implants in rabbits (eye implants intended to be used for cataract surgery in human). The program includes: - intramuscular or subcutaneous implantation test for 4 weeks - 6 test and 6 control rabbit eyes minimum 6 test months We would need the full set of services including preparation of the detailed study plan according to the ISO standards (ISO 11979-5), performing testing in animals and preparation of the final study plan including statistics.Please specify preliminary pricing offer for the services?
Mechanical Laboratory needed for ISO mechanical testing to ISO 594 Testing of Conical Luer Fittings
1. Luer Assembly: Ensures that the Luer specimen can be assembled with minimum axial force and torque.
2. Separation Force: Ensures that the Luer specimen remains attached to the reference fitting when an axial load is applied.
3. Unscrewing Torque: Ensures that the specimen Luer remains attached under a specific unscrewing torque in the counterclockwise direction.
4. Resistance to Overriding: Ensures that the threads cannot be overridden by a specific screwing torque in the assembly clockwise direction.
Electrical Laboratory needed for Diagnostic Medical X-Ray equipment testing: Insulation Resistance test before & after Humidity condition as per BIS norms (IS 7620-1986) we are giving below the details of the tests to be carried out. 1) Humidity Test (IS 302-1979) Humidity >= 95% at 35 to 45 Deg. centigrade for 48 Hrs followed by following test. 2) Insulation Resistance Test (IS 7620-1986,6.2.1) Apply 500 VDC for 1 Minute. Insulation Resistance >=2M ohm
Laboratory needed for development of companion animal lateral flow antibody and antigen diagnostic test products including Canine Heartworm, Lyme disease, Ehrlichia canis, Anaplasmosis and in the feline, FeLV and FI .Need USDA required testing for sensitivity, specificity and inter-laboratory validations with securing US source reagents (whole blood, plasma, and serum) In most cases the assays are detecting antibody. In a small number of cases we will be detecting antigen.
Materials Laboratory needed for biomechanical / biophysical testing for medical device burs: ¬Mechanical force of d¬evices test (compress¬ion, Torsion) Biomechanical property of dental burs is important for safety usage so test should assure torsional yield strength, torque, breaking point of dental burs moreover determine compression load force of device on rigid test block. Test apparatus should be arranged for axial force. 5.¬ ¬? compression and fat¬igue test and standar¬ds Fatigue test is especially for multi-use burrs, So company should proves that performance of product does not change after pre-determined numbers of multi- usage.
Medical Device Manufacturer needs medical device laboratory for sterilization validation of device sterilization process. 1.¬ ¬Sterilization method: ¬ We will supply instr¬uctions for a method ¬with step by step ins-tructions and we need¬ to get the steriliza¬tion validation ? the¬y will be autoclaved Yes it is correct but you should validate your steam sterilization parameters, temperature,duration,pressure etc. After you sterilize your products according to your set values. you confirm with sterility test that No Microbial Contamination on products. Cleaning and Sterilization Instructions Spring FG Diamond Burs are non-STERILE, but should be cleaned and sterilized before use and subsequent reuse. .
Ultrasonic Cleaning Procedure Prepare a fresh pH-neutral cleaning solution; place the Diamond Bur in the dedicated instrum
FDA GMP Bioanalytical Laboratory needed for blood testing for platelet yield , %platelet recovery and platelet recovery factor in PRP tubes for obtaining autologus plasma . Use of hematology analyzer to quantify the platelets contained within start sample and platelet concentrate
FDA GLP Pharmaceutical laboratory needed for Active Pharmaceutical Ingredient Testing: Analysis of APIs using test methods: 1) Elemental composition (CHNO) 2) 1H NMR 3) 13C NMR 4) Differential scanning calorimetry (DSC) 5) Thermogravimetric analysis (TGA) 6) X-Ray structure analysis
Toxicology Laboratory needed for toxicity tests and eco-toxicity testing of new molecule used in a Medical Disinfectant for new surfaces. These tests we need to be able to write up a safety data sheet. including: 1) Ecotest Daphia, 2) Ecotest Pseudokirchneriella, 3) Skin irritation, 4) Eye Irritation, 5) Skin Corrosion.
Contract Medical Device Laboratory needed for FDA Testing of endotracheal tubes (ETT) to FDA recognized standards.
? ISO 5356-1 (2015), Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets ? AAMI ANSI ISO 5361 (2012), Anaesthetic and respiratory equipment Tracheal tubes and connectors
FDA GMP Medical Device Laboratory needed for biocompatibility testing of polypropylene mesh for medical use for a 510(k) application in accordance with the Blue Book Guidance G95-1, (Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing), acceptable test results should be supplied for the biological tests listed below. Standard protocols such as those identified by the USP or ASTM should be used in conducting the biocompatibility testing, if possible. Such tests should be performed on devices ready for surgical use (i.e., after manufacture, sterilization and packaging for commercial distribution). Cytotoxicity Sensitization Irritation or Intracutaneous reactivity Systemic toxicity (acute) Genotoxicity Implantation (with histology of the surrounding tissue) Hemolysis Pyrog
Packaging laboratory needed for ASTM transportation testing for the new medical device packaging box according to ASTM D4169-09 as per below: Please help to quote the test as below, Distribution Cycle 13, Assurance Level III. Test sequence as below: 1. Temperature and Humidity Conditioning 2. Schedule A: Handling 3. Schedule C: Vehicle Stacking 4. Schedule F: Loose-load vibration 5. Schedule I: Low Pressure 6. Schedule E: Vehicle Vibration 7. Schedule J: Concentrated Impact 8. Schedule A: Handling
Biomaterials laboratory needed for in-vitro surgical sealant testing 1. Burst test of surgical sealant (2-PEGs) as per ASTM F2392. 2. Gel Time test - surgical sealant (2-PEGs) 3. Swell Test - surgical sealant (2-PEGs) 5. Gel Mixing test - surgical sealant (2-PEGs)
FDA Electrical medical device laboratory needed for Skin massager testing: 2. FDA Product Code : PBX 3. Performance test standard ? IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance. ? IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility ? Requirements And Tests. ? IEC 60601-2-2: Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories. ? IEC 60601-2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosme
ILAC certified laboratory needed to perform testing of instruments and systems against IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests and ISO 14457:2012, Dentistry Handpieces and motors
Medical Device CE Mark microbiology certification laboratory needed for CE certification testing of opthalmology multi purpose contact lens solution. CE require the following three new tests for multi purpose solution. 1) Antimicrobial activity test in accordance with ISO 14729. 2) Compatibility test between contact lens care products and contact lenses performed according to ISO11981 3) Preservative efficacy test according to ISO14730 Please specify the estimated price and testing time for each tests if that is available
LONG-TERM TESTING Clinical Central Laboratory processing blood and plasma needed for product development and optimization studies microfluidic devices and their components to study the effect or interference of devices on blood chemistry and overall specimen integrity.
Initially, we would like to send a few samples (n=10) for a complete blood count (CBC) and comprehensive metabolic panel (CMP) to determine baseline values. After we have identified any significant differences in samples exposed to a variety of conditions, we would be interested in continued testing by your company for optimization of our products. There would be no chemicals, drugs, or hazardous substances in contact with the specimen at any time? just inert molded plastics and rubber.
Please specify t cost may be associated with these types of analyses.
Medical Devices manufacturers of surgical instruments and implants in India needs microbiology laboratory of disinfectant viral efficacy testing of Natural and Organic Disinfectant for various applications and uses.
The active ingredient of this product is Citrus Aurantium amara extract in the form of Bioflavonoid complex, also commonly known as Bitter Orange extract classified under the CAS No. 72968-50-4.
We are quite sure that this product would help the society and the Population at large in preventing or controlling the spread / outbreak of any viral epidemic in the future.
I request your goodselves to kindly provide me a lab contact, to discuss further.
Thanking you and looking forward to receive your early communication in this regard.
With best regards, For General Surgical Company India Pvt Ltd,
Medical device company needs GLP laboratory for quality control of Ophthalmic viscosurgical devices, according to ISO 15798:2013, Ophthalmic implants Ophthalmic viscosurgical devices
Required tests: concentration, molecular mass distribution, shear viscosity, elasticity, pH, chemical and biological contaminants (heavy metals, proteins, nucleic acids, residual IPA), osmolality, spectral transmittance, particulates, refractive index, bacterial endotoxins test, sterility test, Hemolytic streptococcus hemolytic test
Medical Device Product Safety Laboratory needed for Stability Testing and Biodegradability Testing of Nature latex foley balloon catheter ,Scalp vein sets, feeding tube (PVC) ,and other surgical disposable product to ISO 10993, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process. send test quotation
US Microbiology laboratory needed for comparison study of two different antimicrobial agents using a time kill study. Microorganisms to be studied are Pseudomonas aeruginosa, Staphylococcus aureus, and Aspergillus niger. I want testing at 3 time points, 1 min, 3min, and10 minutes.
Medical Device Company needs Medical product safety laboratory accepting quotes for conducting biocompatibility testing of a (laminated) fabric sample to ISO Standards used in medical device: Cytotoxicity ? ISO 10993-5 Sensitization ? ISO 10993-10 Irritation/Intracutaneous ? ISO 10993-10
Thanks in advance.
Opthalmic Medical Device Company needs Europe or USA Laboratory for determination of cyanide level on a medical device (electrode)
Medical devices manufacturer of FDA class I,Ila and III medical devices needs India NABL laboratory for biocompatiability studies
Medical Device company needs laboratory for staining with Toluidine-blue on our samples (hydrogels) and pictures (5x, 10x and 50x) magnification.
Medical Technology laboratory needed for medical device testing to 60601-1 Medical electrical equipment?Part 1: General requirements for basic safety and essential performance
60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Virology Laboratory needed for performance testing of an ultraviolet germicidal irradiation (UVGI) device used to kill H1N1 influenza virus deposited on respirator coupons. Experiments needed to evaluate the performance of the device using other viruses. We are requesting a quote to evaluate the performance of the device using the following viruses: H5N1 (low path); H7N9 (low path); H5N9; SARS; and MERS-CoV. We will provide the UVGI source and provide training on the method.
Medical Device manufacturer needs FDA GMP Product Safety Laboratory for Toxicology Testing to support FDA 510K application
a) A comprehensive scientific justification for the use of a additive containing heavy metals in a medical device b) Extractables and Leachables Testing on the final finished device, using an exhaustive extraction at 50oC for 72 hours in both a nonpolar and polar solvent c) A dermal risk assessment for each chemical extract characterized in the solvents following the Extractables and Leachables Testing
Pls comment on your proposal
Biophysical Laboratory needed for ISO Testing of medical implant. The material is Metal. It is to ensure that the design does not fail under standardized conditions for example ISO 9585:1990, Implants for surgery Determination of bending strength and stiffness of bone plates
Medical Device company needs biomedical laboratory to provide a quote for CLSI EP07 Interference Testing in Clinical Chemistry on with Neisseria gonorrhoeae and Chlamydia trachomatis.
Microbiology laboratory needed for medical fabric testing for bacteria-resistance. It is nylon taffeta 70 denier with a pic waterproof backing. The same material used for mattress liners in hospital and nursing home settings. I m looking to getting more information s to what types of testing you would do, what certificates can be granted, and an estimate to the cost for these services.
University researcher needs India biomechanical laboratory for bone testing: 1) porosity 2) Mechanical test like compression and tensile.
US Microbiology Laboratory needed for EN ISO Microbial Analysis to EN ISO 22612 Dry Micobial Penetration test
India Microbiology Laboratory with ISO/IEC 17025 NABL Accredition needed for bioburden testing, bacteriostasis and fungistasis testing
Gastroenterology Preclinical Product Safety Contract Research Organization (CRO) needed for weight loss study with capsule inserted in the stomachs of 6 genetically obese mice and then have mice observed for weight loss.
Eye wear company imports eyeglass frames from Italy and would like FDA GMP laboratory for certification testing that frames are made from FDA approved raw materials.
Medical Device Company needs laboratory to provide quote for testing of DEHP, Latex and Phthalates on catheter. Catheter is composed from various materials: Gray Pellethane - proximal hub, Yellow - pellethane - body, Air valves - PVC, Blue & yellow Pebax - distal end, Grey Pebax - distal hub.
Medical Device Company needs laboratory for Particle count testing in accordance with clause 14.2 of EN 45502-1:1997, Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer.
Microbiology laboratory needed for pyrogen testing for a medical device and components. the active ingredient is photosensitive and testing under yellow lighting would be required. None of the materials used in the device have radioactive properties
LONG-TERM ONGOING: UK or Denmark GLP Laboratory needed to obtain a quantitative determination of the following components : ? Dipalmiotylphosphatidylcholine (PC16:0/16:0) ? Total Sphingomyelin (SMtotal) ? Total Phosphatidylcholine (PCtotal) ? Total Phosphatidylglycerol (PGtotal) ? Phosphatidylinositol (PItotal) We prefer to use the concentration unit of nmol/ml, and expect that the components are present in the following concentration ranges : ? PC16:0/16:0?0,5 - 150 ?nmol/ml ? SMtotal?0,1 - 40 ?nmol/ml ? PCtotal?1.0 - 500?nmol/ml ? PGtotal?0,3 - 50?nmol/ml ? PItotal??2 - 30 ?nmol/ml
Eastern Europe medical device laboratory needed for Personal Lubricant Ge testing. Two tests; 1) Condom compatibility test 2) Spermicid Test (Our product does not kill or kill sperm)
Microbiology Laboratory needed for microbial testing of manufactured medical device parts for specific microbiological requirements. We are a contract plastic manufacturing company for medical products and have a specific test requirements. for
TAMC (Total Aerobic Microbial Count) -9999 0 200 cfu/gm STM-00412, STM-00411 Note 1 TYMC (Total Yeast & Mold Count) -9999 0 20 cfu/gm STM-00412, STM-00411 Note 1
Preclinical Laboratory needed for in-vivo gastroenterology study to get a first estimation of the likelihood that a gastroenterology physical barrier might become twisted or entangled in some fashion that it could cause harm to the animal and my inference to any future human trials. Another objective is to identify any undesirable elements associated with food waste that has not had its nutrients removed in a normal manner.Need to have specially sized condom like sleeves emplaced in the stomachs of 6, genetically obese lab rats and then have their diets, weights, and stools monitored for two months. These condom like sleeves will be encapsulated in gelatin capsules. Once emplaced in the rat stomachs, they are expected to assume a round diameter two large to pass into the rat intestines. As food is pushed into the intestines, this condom l
Medical Device Laboratory needed for EUropean Pharmacopeia Testing of Surgical threads to European Pharmacopeia [8.0] Monograph 01:2008:0324, IDENTIFICATION For (Silk sutures) Identification of silk: A. Dissect the end of a suture, using a needle or fine tweezers, to isolate a few individual fibres. The fibres are sometimes marked with very fine longitudinal striations parallel to the axis of the suture. Examined under a microscope, a cross-section is more or less triangular to semi-circular, with rounded edges and without a lumen. B. Impregnate isolated fibres with iodinated potassium iodide solution R. The fibres are coloured pale yellow. For UNILIN (Linen Sutures). Identification of linen A. Dissect the end of a suture, using a needle or fine tweezers, to isolate a few individual fibres. Examined under a microscope, the fibres are se
ISO 17025 accredited Medical Device Laboratory needed for ASTM Testing of Hernia Mesh - 3 types (Flexpro mesh, Polyester mesh, polypropylene mesh) ? Cotton Umbilical Tape. Tests required. 1. Stiffness Test as per ASTM-D1388-14. Test may be conducted with option-1: Cantilever or option-2: Heart Loop 2. Bursting Strength of Textiles - Constant-Rate-of-Traverse (CRT) Ball Burst Test as per ASTM-D3787-15 3. Breaking Strength and Elongation as per ASTM-6775-13 Please make sure your office is ISO 17025 accredited
Medical Device Laboratory needed for ISO Compliance testing on Temporary Cardiac packing wire & Stainless steel wire). 1. Compliance verification report for Temporary Cardiac Pacing Wire as per EN 60601-1:2006/A1:2013, EN 60601-1-2:2007/AC:2010, EN 60601-1-6:2010 2. Chemical Composition Test Report for Temporary Cardiac Pacing Wire as per BS ISO 5832-1:2007 3. Mechanical Properties Test Report for Temporary Cardiac Pacing Wire as per ISO 10334:1994 4. Chemical Composition Test Report for Stainless steel wire as per BS ISO 5832-1:2007 5. Chemical Composition Test Report for NEEDLE as per ISO 7153-1:1991 & ISO 13402:1995
URGENT: USA FDA GMP Medical device laboratory needed for device functionality and performance testing of medial devices used to administer biological drugs intra-parentally to humans. These devices include auto-injectors, pre-filled syringes, etc. Testing includes break loose/glide force testing, flow testing, simulating transportation and drop testing, etc.
EPA laboratory needed for ISO 10993 and/or The Ex Vivo Porcine Skin Test. testing of a device that converts an aqueous saline solution into a cleaning & disinfecting solution by electrolysis. We would like to make a claim indicating that at 200 ppm FAC and 400 ppm FAC the resulting solution is harmless to skin and other human and animal tissue including eyes. We believe that to make these claims the EPA requires that we publish results of ISO 10993 and/or The Ex Vivo Porcine Skin Test.
We would like to be contacted by an EPA approved lab capable of performing these tests.
CALIFORNIA OR TEXAS FDA GMP MICROBIOLOGY LABORATORY NEEDED FOR STERILIZATION VALIDATION TESTING OF ETO STERILIZED CONSUMER BANDAGES . 4 products one full container
large medical device manufacturer needs FDA GMP toxicology laboratory for toxicology testing: Modified draize-95 test to meet FDA requirement
Biomedical Laboratory needed with MRI Suite for MR headset testing. To be tested for attenuation and chamber noise test. anutation test and any sort of chamber testing along with applicable 510k Testing like RF heat
FDA GMP Biomedical laboratory needed for FDA testing of personal lubricants for 510k submissions Condom compatibility testing.
Medical Device Manufacturer needs laboratory for disposable gown and drape testing to Association for the Advancement of Medical Instrumentation AAMI level of disposable Gown and Drape, we need to test AATCC 42, AATCC 127, ASTM F1671, ASTM F1670
Preclinical Laboratory needed for Biocompatibility Study for implant material SS 316L as per ISO 10993 , Biological evaluation of medical devices
Biomechanical Laboratory needed for mechanical testing of orthopedic implants for CE/ FDA certification
Medical Device Product Safety Laboratory needed for Stability Testing and Biodegradability Testing of Nature latex foley balloon catheter ,Scalp vein sets, feeding tube (PVC) ,and other surgical disposable product to ISO 10993, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process 1.In vitro cytotoxicity test 1.3test on extract 3.Irritation test 3.animal Irritation test 5.Sensitization test 5.2 maximization method- guinea pig 8. Implantation test 8.1 subcutaneous Tissue 8.1.1 short term (4 week to 12week) please send us quotation
Medical Device Manufactrer needs Biomedical Contract Laboratory to generate a pressure map of a device pressed against a surface (to simulate skin contact). We'd like to have a 2D heat map of the pressure exerted on the surface. I've seen a film that may be suited to this, but am open to alternate options.The resolution needs to be high enough to accommodate millimeter scale differences.
Medical Device Laboratory needed to perform a test that will measure the volume (or amount) of a gas which flows out from a bag made of silicone rubber. the bag is under pressure and i need to know how much gas got out of the bag in specific time.
SAMPLE PREPARATION: Large medical device company needs laboratory to prepare samples: Polish/grind circular disc that are 15±1 mm in diameter and 1.4±1 mm thick. Grind each specimen through diamond-embedded media having a nominal grit size of 30 ?m to 40 ?m and final polish on media having 15 ?m to 20 ?m diamond grit.
Pennsylvania, New Jersey or Maryland Medical Device Laboratory needed for Product safety and efficacy testing for nasal strips Scientific research for Efficacy to gaining insight on percentage of nasal airflow variances
USA FDA GMP BIomedical laboratory needed for FDA medical suture evaluation of 8 suture samples
Ireland bioanalytical laboratory needed to test the hemocompatibility and coagulation times of human blood in a needle . to investigate different surface treatments to increase the coagulation times of blood within the needle lumen.
Medical Device Safety Laboratory needed for amazon safety testing Polypropelene Homopolymer contact lens case to sell on Amazon. Product testing document OR safety assessment document, whichever is the easiest and least expensive to obtain.
Biochemistry laboratory needed for calibration of the sensitivities of immunoassay tests. We calibrate the sensitivities of the immunoassays using calibrators. We are interested in a lab who can assay controls for us to know the quantitative value of certain analytes in the control At the moment, we are interested to assay Drug of Abuse calibrators using HPLC or Gas Chromatography method. We are also interested to assay an hCG hormone calibrator. We will provide the calibrators. HPLC/Gas chromatography testing of Drugs of Abuse controls.
ISO 17025 or FDA GLP Accredited Test institute needed for catheter and catheter accessory biocompatiability testing of these materials according to related standards to Test Standard: 10993-1. We will focus on products which will stay more than 30 days in body. 2. nd product: Implantable Gel material Please give me price and make me informed about the procedure and accreditation status
USA genetics laboratory needed for Genetic Sequencing for Illumina testing- pediatric inherited disease panel and autism panel
UK MHRA Bioanalytical laboratory needed for verification testing for justification of the use of 263 hamster adapted strain of scrapie agent for viral inactivation testing of bovine collagen hemostatic medical device in 2014 rather than the 301V mouse strain of BSE agent believed to be more predictive. They want us to justify the use of 263k and why it is still adequate. We are looking for an expert laboratory to write us a justification memo of the strain 263k is still a good method to use. Is this something your laboratory could help us with and quote?
Bioanalytical laboratory needed for bioavailability testing for Stability testing on transdermal vitamin B12 patch for 3 year shelf-life
Medical Device Laboratory needed for Bioavailability and Stability testing on transdermal vitamin B12 patch. We have a list of protocols to follow for this test, but essentially need to confirm bioavailability of ingredients for 3 year shelf life.
USA biomedical laboratory needed measure the volume displacement over time of a self inflating device. Need a high level of accuracy because of the small size of the device
USA biomedical product safety laboratory needed for Medical Device Directive Bio-compatibility and Microbiological Safety testing performed on our Temporary Crown and Bridge Material for compliance to Medical Device Directive 93/42/EEC EN ISO 10093-1 EN ISO 11737-1:2006
Biomedical laboratory needed for measurement of drug elution rate from coronary stents
Southeast preferred United States laboratory needed for ASTM Lead Equivalency and Attenuation testing per ASTM F2547-06 standard lead free material tested for Pb equivalency and attenuation at 60kvp, 80 kvp, 90kvp, and 100kvp
Medical Device product safety laboratory needed for Amazon Healthcare product safety testing performed on a very heating pad I'm selling on Amazon. In order to be listed in the Health Care category, I need certification that safety testing has been performed by a lab.
This product is literally a cotton bag filled with flax seed and scented oil - about as simple as it gets. It is made by hand in the USA.
I'm interested in understanding how much it would cost to have this product tested and what you need in order to complete such testing. I'd also like to confirm that testing performed by your organization will be considered sufficient & acceptable by Amazon as they assess my product in the "Health Care" category.
Thanks for your time and attention.
COnsumer Products Safety Laboratory needed for safety assessemnt to Amazon seller requirement: product testing document OR safety assessment document. My product is made of polypropylene (PP) and touches only the contact lens case, not the lenses themselves.
Asia biomedical laboratory needed for FDA 510k opthalmic shunt testing : Aqueous Shunt Gravity Flow Test: to evaluate the pressure/flow characteristics of an aqueous shunt when exposed to a decreasing pressure gradient in an aqueous environment. The experimental data obtained from this test may be used to calculate a theoretical resistance to flow for the aqueous shunt. Constant Flow Test: to evaluate the pressure/flow characteristics of an aqueous shunt when exposed to a constant flow rate (mimicking physiological flow rates) in an aqueous environment. The experimental data obtained from this test may be used to calculate a theoretical resistance to flow for the aqueous shunt.
California Materials laboratory needed for ASTM rheology Testing to determine levels of cure in samples of liquid silicone rubber to ASTM D6601-12, Standard Test Method for Rubber Properties?Measurement of Cure and After-Cure Dynamic Properties Using a Rotorless Shear Rheometer
Texas Laboratory needed for ISO Comparative testing for contact lens solutions to ISO 11981 2nd ed 2009 Ophthalmic optics Contact lenses and contact lens care products Determination of physical compatibility of contact lens care products with contact lenses
ISO 11986 2nd Ed 2010 Ophthalmic optics Contact lenses and contact lens care products Guidelines for determination of preservation uptake and release
Toxicology laboratory needed for cytotoxicity testing of PVC Films used in the medical industry. I?m also interested in quotes for USDA class 6 testing.
India dentistry laboratory needed to check erosion on natural teeth using dental wet wear abrasion tester.
Large Medical Device Manufacturer needs materials laboratory for Haze and transmittance testing on a flexible polymer Sample size < 20
Medical Device Laboratory needed for USP Testing of sutures to USP 861: Suture- Diameter USP 871: Suture- Needle Attachment USP 881 : Surgical Suture- Tensile Strength
Medical Device Materials Laboratory needed for ASTM Condom Testing to ASTM D7661 - 10 Condom Compatibility Test
Physical Laboratory needed for medical device vibration testing and physical impact testing of Titanium Osmotic Pump in Medical Devices
US Non-GLP Medical Device Contract Research Organization CRO needed for non-GLP broncoconstriction study of implantable neurostimulator.
FDA Plastics and Polymer Laboratory needed for ASTM Testing of Polypropylene (FDA-CFR-177.1520) Test: Density (ASTM method D1505?68); Melting point (ASTM method D2117?82); Hexane Extractables; Xylene Extractables Material: Polyethersulfone (FDA-CFR-177.2440) Test: water, 50% alcohol, 3% acetic acid, N-heptane extractables Material: Polytetrafluoroethylene, perfluoroalkoxy (FDA-CFR-177.1550) Test: water, 50% alcohol, N-heptane, ethyl acetate extractables (FDA-CFR-177.1550)
USA Materials Laboratory needed for Intermittent testing of 3 foam sample hardness over 30,60,90,120, and 150 wash cycles. Machine wash warm, tumble dry low.Wash & Dry Equipment & Durometer to test foam hardness changes
Biomechanical Laboratory needed for CE Mark Testing of Biomechanical Titanium Material for Titanium Purpose
Canada / US Microbiology Laboratory needed for Repeat cleaning and steam sterilization cycle test for medical device component.
Physical Laboratory needed for medical elastic bandage testing for the force it generates at 50% extension and various elongations. The customer states it must be 1.35 foot pounds at 50% extension.
Medical Device Product Safety Laboratory needed for Stability Testing and Biodegradability Testing of Nature latex foley balloon catheter ,Scalp vein sets, feeding tube (PVC) ,and other surgical disposable product to ISO 10993, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
Microbiology Contract Laboratory needed for conducting a stability study for one of our products that require 3 chambers at 25C/50%RH. This study will start in November, 2015 at the earliest. These chambers will need to be dedicated exclusively for us.
Packaging Laboratory needed for ASTM Testing to ASTM D4169, Standard Practice for Performance Testing of Shipping Containers and Systems
Medical Device Physical Laboratory needed for mechanical function testing of reusable device after Cleaning and steam sterilization. 63 reusable laparoscopic handles tested according to the IFU for 100 repeat clean/sterilize cycles. Test the mechanical function after every 10 cycles.
Microbiology Laboratory needed for anti-microbial efficacy testing of Anti Microbial Surface Coating with various Virus like H1N1 , Corona etc.
Medical Device Product Safety Toxicology Laboratory needed for Product Safety Studies including Cytotoxicity Testing & endotoxin testing
Medical Technology and Microbiology Laboratory needed for stability accelerated ageing testing & sterility test for the product has been manufactured in 05/2013 and sterilized by Ethylene Oxide. This product expire in 05/2016 so we want to perform the accelerated ageing test and sterility test to extend the shelf life for another 2 years (to 05/2018).
Medical Device Laboratory needed for solvent removal process validation testing of a drug/device combination product. Please provide a quotation to conduct a TGA scan on a single sample (to establish conditions under which all the ethanol is driven off) followed by testing of six samples (three batches in duplicate) to validate the solvent removal capability of the manufacturing process.The device is manufactured using a Class 3 residual solvent (ethanol) which is the only volatile species likely to be present. The ethanol may not be readily volatilized because it is a component in a viscous gel.
Medical Device laboratory needed for efficacy study of a new contact lens cleaning device: comparison study in cleanness (how much dirt, built up protein, particles, bacteria and micro-organisms are left after the lens has been cleaned) between a normal rinse and rub and this new device. Is this something your lab could potentially do?
Medical Device Product Safety Laboratory needed for FDA 510k biocompatibility testing to ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)]
Need to do testing for FDA 510k submission for Zirconium Milling disks
Medical Technology laboratory needed for Laser resistance testing per ISO 11810 for disposable surgical drape
USA product safety laboratory needed for product safety assessment testing to sell a skin patch on Amazon.
USA Medical Laboratory needed for GS/MS water testing: Detecting approximately 200 to 400 ppb ethylene oxide in water sample
Medical Device Laboratory needed for Residual ethylene oxide and ethylene chlorohydrin testing of medical devices in compliance with ISO 10993-7
Packating Laboratory needed for ISO 11607 and FDA CE ISO 13485 requirements for Medical device packaging testing for gamma sterilized device, aging, validation, report , SOP, IQ, PQ, VQ Etc. Needed as soon as possible
Diagnostics manufacturer needs bioanalytical laboratory needed for Residual Moisture Analysis of lyopholized serums.
Preclinical Medical Device Laboratory needed for Medical Devices Vibration testing, Medical Devices Impact, Medical Devices Electromagnetic Compatability Testing EMC Testing
Medical Device Laboratory needed for product development testing of sample collection product that is compatible with Vitros and Cobas instruments as well as manual ELISAs. We're looking for labs to finish product development with and direct lab tests to. We're planning to offer on-demand medical testing to e-doctor sites and apps.
Polymer test laboratory needed for BSE/TSE testing and chemical analysis of medical device injectors
India biomedical laboratory needed for ISO dental implant testing: Cyclic load testing on dental implants 15Hz for 5 million cycles and Dynamic fatigue testing ISO 14801 on dental implants
India biophysical laboratory needed for dental implant testing: Dynamic fatigue testing ISO14801 on dental implants to ISO 14801, Cyclic load testing on dental implant at 15Hz -5 million cycles . 20 implant testing in a span of 2 years.
Medical Device Microbiology Laboratory needed for sterilization validation testing of Class 1 medical device used as implants.
Microbiology Laboratory needed for Microbiology Testing of Neurology Electrode Medical Devices
FDA registered, cGMP and ISO biomedical / toxicology laboratory needed for product safety testing of a transient use(<15 minutes), mucosal (non-breaching), device:
1. ISO 10993-5 Cytotoxicity testing
2. ISO 10993-10 Sensitization Testing
3. ISO 10993-10 Vaginal Irritation Testing
Biomedical and Product Safety Laboratory needed for breast implant testing toISO 10993. We would like to test: 1) 2) INTRAGASTRIC BALLOON 3) BREAST IMPLANT on the next effects: 1) CYTOTOXITY 2) IMITATION (INTRACUTANEOUS REACTIVITY) 3) SENSITILIZATION 4) SYSTEMIC TOXICITY (ACUTE) 5) IMPLANTATION 6) SUBCHRONIC TOXICITY 7) GENOTOXITY
FDA GMP medical device company needed for contact lens testing in compliance to go for FDA approval
Medical Device Materials Laboratory needed for contact lens testing services provided for measurement of Ion Permiability, Oxygen Permiability, Power, Light Transmission, Diameter, Contact Angle, and Visual Inspection of contact lenses as well as pH, Osmolality of storage solution and package condition.
Healthcare System needs Microbiology Laboratory for suture testing to determine the source of a cluster of post operative infections
ISO or FDA GMP Boston product safety laboratory needed for wound dressing product safety and biocompatibility testing.
ISO and FDA GMP Medical Technology Microbiology Laboratory needed for ISO surgical instument sterilization validation.in need of a lab that can confirm inactivation of prions via NaOH or sodium hypochloride bath
Product Safety Laboratories needed for product safety testing to EN ISO Standards:EN ISO 10993-10 Biological evaluation of medical devices. Tests for irritation and delayed-type hypersensitivity, , EN ISO 10993-05 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity , 10993-03 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Europe biomedical laboratory needed for CE Mark testing protheses testing of tubular adapters for lower limb prostheses (amputees) ISO Standard 10328:2006 mechanical tests (torsional testing - static testing) and
Structural tests : static test under load Structural tests : static rupture tests Structural tests : cyclic tests Torsional tests
Southern California Biomedical Laboratory needed for Biomechanical analysis Examine the potential of device for building strength and mass and for rehabilitation
Boston Area Bioanalytical laboratory needed for medical device research experiment with the ability of a water-jet device to cut and consume various Collagen types. Specifically it's ability to differentiate between type 1 and 3 collagen.
Medical Device Materials Laboratory needed for ASTM biodegration testing to support biodegradable claim for a patient belonging bag. We're hoping to get the test done per a standard; we've identified ASTM D5511 (Anaerobic Biodegradation of Plastics) or ASTM D6954 (Oxo-Biodegradable Plastics).
Asia polymer laboratory needed for ASTM Testing to test PEEK material according to ASTMF 2026. Please kindly let me know if you have this facility and if so, please send me a quotation.
India Medical Device Laboratory needed for Radiopecity Testing of Microcatheter (Plastic Extuded component) using X-Ray System-Glenbrook Technologies MXRA, MXXR
Analytical Chemistry Laboratory needed for research testing on the vegetable oil used in a medical device used in hospitals to support "mold and hold" patients to allow relief from pressure ulcers. Tried Soy Oil in device and it works well, but developed an odor, and varied fom load to load.
United States textiles laboratories needed for verification testing of the compression rating & fiber content of compression socks.
Singapore or USA medical device laboratory needed for ASTM MRI / radiopaque testing of endotracheal and tracheostomy tubes to ASTM F2503-13, ASTM F2213 and ASTM F2503
Bioanalytical laboratory needed for TSE / BSE validation testing to validate that research products is 100% free of TSE Transmissible spongiform encephalopathies/BSE Bovine Spongiform Encephalopathy.
USA Microbiology Research Laboratory needed for tissue testing. Determine the presence of biofilm from infected tissue such as a tissue staining methods that identify biofilm?
Medical Device Laboratory needed for ANSI Testing Device of an aqueous ocular shunt to ANSI Z80.27, Ophthalmics - Implantable Glaucoma Devices. The test would involve characterising the pressure/ flow characteristic.
United States Toxicology Laboratory needed for toxicology testing on a variety of plastic materials for orthodontic usage.
USA materials laboratory needed for Drapability testing of a medical sterilization wraps (textile) from 2 conditions of differing autoclave time, described below. There will be 40 wrapped samples total (10 samples per condition and item number
United States Laboratory needed for 12 lead electrocardiograph testing against IEC/AAMI standards ISO 60601-1, ISO 60601-1-2, AAMI EC11
United States medical device laboratory needed for formulation testing to add flavoring to denture adhesive remover in Powder form.
Medical Device Laboratory needed for ISO Testing of medical device: Pressure/force testing - need to measure how much force a fluid has as it is ejected from a device test to: ISO 5367 and EN 12342
Medical Device Laboratory needed for Medical Device Testing to ASTM 640-12, Standard Test Methods for Determining Radiopacity for Medical Use
Northern California biochemical laboratory needed for formulation testing to Finalize chemically based optical sensor formulation for use in a disposable medical device and develop manufacturing specifications
USA Biomedical Laboratory needed for ISO Testing of Japanese polyester fiber to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation)
United States FDA GMP bioanalytical laboratory needed for condom compatibility testing or water-based personal lubricant for condom compatibility. The data will be used to get approval through 510K approval pathway.
Biomedical Laboratory needed for insulin pen testing: test lab to carry out Dose accuracy test (As per ISO 11608-1:2014) of insulin pen device.
ISO Ontario, Michigan, or New York Biomedical Laboratory needed for Biomedical Testing of Plastic models of the Pelvis (axial torsion, strength until failure, etc.) using an Instron (preferably table top) materials testing machine
Medical Device Manufacturer needs independent test laboratory for verification testing of device that measures [CO] in expired air. We calibrate this device using primary standards from a well-known supplier. As a risk mitigation, we would like to have an independent laboratory verify the gas concentrations in these primary standards. The two mixtures of greatest interest are: 5 ppm ± 1% CO, balance N2 and 25 ppm ± 1% H2, balance N2.
USA Medical Device Laboratory needed for testing to EN388, Gloves Giving Protection from Mechanical Risks: Resistance to abrasion, Blade cut resistance, Tear resistance, Puncture resistance
Bioanalytical Laboratory needed for development testing for commercialization of isothermal assay (LAMP)
East Coast USA FDA GMP Bioanalytical Laboratory needed for testing analytical specificity of a rapid antigen testing. Testing potentially cross reacting organisms (parasites, viruses, bacteria) in whole blood with our rapid test. testing of 23 BLS2 organisms - some may have restrictions associated with them. Testing of BLS3 would be also requested, but not required if BLS3 facility not available.
URGENT: India Product Safety Toxicology Laboratory needed for Toxicokinetic Study: Biological Evaluation testing of product as per ISO 10993-16:2010 (Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables).
Clinical bioanalytical Laboratory needed for medical device diagnostic kit's effectiveness for for testing testosterone antibodies in pregnant women's urine
New Jersey bioanalytical laboratory needed for enzyme analysis of lubricating gel for Enzyme detection (analysis).
United Kingdom medical device laboratory needed for Fatigue testing on breast medical implant device (breast)to ISO 14607 Annex E, Non-active surgical implants. Mammary implants.
Medical Device Laboratory needed for ASTM Testing of air ventilators to ASTM D5466-01 Standard Test Method for Determination of Volatile Organic Chemicals in Atmospheres (Canister Sampling Methodology)
USA Medical Device Laboratory needed for dental sterilization testing to ISO 14457 : 2012 Dentistry ? Handpieces and motors (including Section 5.10 Repocess(250 sterilization cycles) test) Item: Dental Handpiece and coupling. This Requestor requires a Quote. Please respond with a quote.
Canada FDA GMP medical device laboratory needed for personal lubricant testing in support of a FDA 510(k) for the intent to sell in the United States.
Biomechanical Laboratory needed for mechanical testing for our orthopedic implants to procure CE NOTIFIED CERTIFICATE
Medical Technology Laboratory needed for biomedical testing of urinalysis dipstick analyzer device. Analytical performance testing analytical specificity (interference testing) and detection limits for a urinalysis dipstick analyzer device
Medical Device packaging laboratory needed for shipping validation study on non-sterile, single use, medical devices according to: Environmental Conditioning guided by ASTM D4332-14 - 23C ± 2C @ 50% RH ± 5% RH for 72 Hrs - Perform on all 120 units Shipping & Handling guided by ASTM D 4169-14: DC 13, AL I - Test Sequence - 30 post environment conditioned units - Schedule I will not need to be performed since packaging in non-sterile and porous We would require 30 units to be tested, each unit is 22 cm x 20 cm x 4cm.
Laboratory with capacity for measuring radioactivity needed for ceramic dental implant radioactivity testing according to ISO 13356
Biomaterials Laoratory needed for determining the ELASTICITY and ADHESIVENESS and GAS PERMEABILITY of our research product (ongoing) which is a coating to surface of wounds. This coating is film-like and is 0.001 to 0.02mm thick (mean thickness).
Microbiology laboratory needed for pyrogen testing of medical examination gloves. Please indicate test method, price, quantity sample required and duration time
Medical Textile manufacturer needs materials Laboratory needed for breathability testing. (1) Non woven fabric and (2) PU film medical grade. Both materials need to be tested as per: 1. ASTM E 96, Procedure B (upright cup method) or 2. ASTM E 96, Procedure BW (inverted cup method) or 3. JIS L 1099 (desiccant inverted cup method)
FDA GMP analytical chemistry laboratory needed for API Testing of developed test method for a pharmaceutical transdermal patch. We need analytical testing done for these patches. At first we only need one API tested.
Packaging laboratory needed for ASTM Testing or ISTA Testing of Fecal Incontinence Management Device, Class IIa (as per EU regulations), Non-sterile single use device to ASTM D-4169 and ISTA Methods
FDA Medical Device product safety laboratory needed for fda modified draize-95 test for human patch test For low dermatitis claim and no thiurum, carbamate and claim.
Medical Device Product Safety Laboratory needed for ISO10993-5:2009 Cytotoxicity and Sensitization, Irritation or Intracutaneous reactivity testing. is required for our Nasal Suction Tube product. Testing is required to allow the product to meet the standards outlined in ISO10993- Biological Evaluation of Medical Devices. Any number of samples required for the testing can be provided.
In-Vitro Diagnostic Manufacturer needs clinical laboratory for long-term testing of Volatile Organic Compounds (VOCs) found in the breath samples for up to 200 different compounds
Optical manufacturing company of ophthalmic lenses needs Texas materials laboratory for lens testing of UV-reactive coating for viscosity and water content.
USA FDA GMP AND ISO medical product safety laboratory needed for medical devices safety testing of cathether EDV : cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediate pyrogenicity, and hemocompatibility (hemolysis, complement activation, and in-vivo thrombogenicity). Methods and results from biocompatibility testing of your device according to a recognized standard (e.g., ISO 10993-10) and FDA
East Coast US Laboratory needed for medical device testing of: EC53 ECG lead wires and cable
Preclinical COntract Research Organization needed for preclinical studies and biocompatiability testing of medical device implant: implantable membrane for breast reconstruction (tissue reinforcement matrix, class III device), to be associated with tissue expanders and breast implants.
The membrane is a modification of an already implantable silicone membrane, which is modified on the surface by plasma treatment. We would like to know if possible an estimation of the costs and timeframe for the biocompatibility tests in your facility.
FDA ISO California independent lab needed for failure investigation testing for root cause analysis luer lock issue in our breast pumps. I am looking for a lab that can perform root cause analysis.
Medical Device Laboratory needed for physical, safety and biocompatiability testing of around 20 variations of Personal lubricants for FDA 510k submission
South Africa biomolecular laboratory needed for molecular characterization of microbial organisms
Europe FDA GMP Biophysical Laboratory needed for ASTM Testing to ASTM F 2392-04 Standard Test for Burst Pressure Strength of Surgical Sealants. Need to evaluate surgical sealants strength using the ASTM F 2392-04 Standard Test Method for Burst Pressure Strength of Surgical Sealants.
Medical Device Preclinical Contract Research Organization needed for Product Safety Studies: System toxicity (acute) for medical deviceTesting collection system for autologous fat; collecting fat in a container, then immediately reinserting that person's fat back into their body in a different location. ISO 10993 Part 1
US Electical laboratory needed for EMI/EMC Medical Device Safety Testing EMC 60601-1-2 Testing to 60601-1-2 (EMI/EMC) for class II hand-held, wireless (BT/G3) Medical Device
DEA Biomedical laboratory needed to test cross re activity of some substances of urine DOA rapid tests which we manufacture. We will supply the DOA rapids tests and the list of substances that we need to test their cross reactivty with the tests.The substances need not to be spiked to a human urine sample, they can be spiked to distilled water or buffer. The lab will have the responsibility to avail the substances.
USA FDA GMP medical device laboratory needed for bench testing of x-ray sensor testing to support FDA 510k
SOUTH AFRICA BIOMEDICAL LABORATORY NEEDED FOR BLOOD SCREENING KIT TESTING; FOR RAPID ESTABLISHING THE RH (RHESUS)
USA Radiochemistry Laboratory needed for radioactivity Testing of dental materials by the dental standards ISO 13356 and ISO 6872 by gamma spectroscopy. Standards for dental ceramic restoration and implant materials. Samples are fine, processed zirconium oxide powder for producing dental restoration milling blanks.
Asia Laboratory needed for FDA testing of nanotechnology surgical gowns to test textiles for barrier protection against pathogen and blood. against EN13795 (CE mark) and FDA standards. We need to test for AMMI, ASTM1670/1671, EN13795 tests, and general textile tests, to prove that this material is suitable for use in the operation room as surgical gown, with sufficient barrier protection against pathogen and blood.
Asia ISO NABL or ISTA Packaging Laboratory needed for Packaging, Transport and Storage Validation Testing We would like to establish the following parameters for our electrosurgical medical devices (electrodes/forceps) in accordance with ISTA Procedure 2A ? Accelerated Storage Profile ?
Simulating the aging process (according to ASTM 1980-07) to establish an accelerated aging study of 12 month storage conditions from the date of delivery and manufacture. Environment storage conditions are states as 55°C and 90% RH maximum.
Transport and Distribution Profile ?
Simulate the distribution profile (according to ISTA Procedure 2A) an environmental conditioning cycle to simulate the road and air transport of freight from Australia into Europe. Followed by fixed and random vibration testing and drop test.
Note - the device is pla
FDA Toxicology Laboratory needed for cytotoxicity Testing per ISO 10993 -5 for an Adhesive that I am using in a Medical Device that comes into contact with human skin for less than 24 hours. The contact is on average in contact with the victim for less than ten seconds.
East Coast Biological Laboratory needed for FTIR analysis on blood particles from an insulin delivery device
USA, Argentina, Germany, France biomedical labroatory needed for IEC Testing: Ultrasound for physiotherapy - samples - 01 und Stimulator for physiotherapy - samples - 01 und Test for
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
Medical products manufacturer and distributor of conductive medical gels needs biomedical laboratory for establishing the testing criteria for our ultrasound conductivity gels. Will you be able to perform acoustic impedance or attenuation testing for our ultrasound gels? Z=p×V Z= acoustic impedance p = substance density V = speed(Velocity) of ultrasound Velocity (V) = Frequency of ultrasound(f) × Wavelength (?) Sound frequency 2MHz ? 10MHz Temperature 25° C
Biomedical Laboratory needed to measure the concentration of oxygen released from a biomaterial over time
Product Safety GLP Laboratory needed for OECD eye irritation potential of four products with study design in accordance with the OECD TG 405, EU Guideline B.5 and conforming to the OECD Principles of GLP. Therefore we would like to ask if you could provide us a cost estimate, time-line, invoicing procedure, details of sample delivery and a relevant test protocol for In Vivo Eye Irritation GLP testing. The samples are aqueous dispersions of styrene-butadiene based polymers including further additives. The pH ranges for the samples are: Sample A ? pH 5-6 Sample B ? pH 5-6 Sample C ? pH 10-11.5 Sample D ? pH 9.5-10.5 Would it be possible to also let us know a provisional timeline until the final test results could be provided? We would like to send samples at end of November / beginning of December.
Medical Device Manufacturer needed for accelerated aging and post accelerated aging tests medical orthopedic implant. The specifications are Medical package (ISO 11670) -Accelerated ageing ASTM F1980 Visual test ASTM F1886 -Seal Strength /peel test ASTM F88 -Dye penetration (package integrity) ASTM F1929 - microbial barrier ASTM F2638 email: phonenumber: address:
Dental manufacturing company needs preclinical contract research organization for medical device product safety studies including oxicology and biocompatibility studies on medical device of macroporous hydroxyapatite powder (calcium phosphate) used in dentistry, maxillofacial surgery, orthopedics and traumatology in order to replace or substitute the bone tissue. In order to check its biocompatibility we need following tests according to ISO 10993-1: - Cytotoxicity. - Sensitization. - Irritation or intracutaneous reactivity. - Systemic toxicity (acute). - Subacute and subchronic toxicity. - Genotoxicity. - implantation. We would appreciate a quotation about these tests. Many thanks.
Asia Biomedical Laboratory needed for Accelerated aging testing for medical implants to ASTM F1980,Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Microbiology laboratory needed for bioburden testing on woundcare dressing sterilized via E-beam radiation to calibrate the radiation levels.
Biomedical Laboratory needed for therapeutic wound dressing testing including: initial biocompatibility testings for: -cytotoxicity -sensitization -irritation Intended use will be for: over the counter use -minor abrasions -lacerations -minor cuts -minor scalds and burns under supervision of a healthcare professional -MRSA wounds -diabetic ulcers -leg ulcers (venous status, arterial ulcers and leg ulcers of mixed etiology) -pressure ulcers/sores (partial and full thickness) -1st and 2nd degree partial thickness burns -donor sites and traumatic and surgical wounds
FDA cGMP Medical Device Product Safety Laboratory needed for Cytotoxicity (1 item) Sensitization (2 items) Irritation / Intracutaneous (2 items)
Toxicology Laboratory needed for Cytotoxicity testing of medical device packing material
Asia Biomedical Laboratory needed for ANSI / AAMI / ISO and ASTM Accelerated and real time aging studies to be conducted on sterile medical device to calculate shelf life to ANSI/AAMI/ISO 11607-1:2006ASTM F1980-07 (2011)
University Researcher wants Product Safety Toxicology Laboratory for Carcinogenicity Researc Studies: in vitro testing of a new material to be used for discovering leakage in electric cables. What tests you recommend, how long does it take, and how much does it cost per sample?. Thank you.
FDA Laboratory needed for evaluation of organic oil marketed under FDA as "personal lubricant". Need oil analyzed as well as tube packaging materials. 510(k) consulting services neede as well. What is recommended complete process to achieve FDA approval and accompanying charges for services?
Dental Medical Device Manufacturer needs France biomedical laboratory for ISO 21563 dental alginates testing - 2 samples
Aalytical laboratory needed for California Proposition 65 Nitrosamine Testing on rubber. Please respond quickly so we know if we are moving forward with your laboratory.
FDA Medical Device Preclinical Laboratory needed for medical lubricant testing for FDA 510k: cytotocity., vaginal irritation and systematic toxicity,maximum sensitization, condom compatablity and All tests needed for personal lubricants including condom compatibility.
India Laboratory needed for analytical testinf for Analytical report in respect of IV Extension Sets PVC Free. ( Medical Device ) HS Code 9018.
Europe GMP Biomechanical Laboratory needed for ASTM Testing of surgical adhesive: F2255, F2256, F2258
Preclinical Contract Research Organization CRO needed for Performance testing in a canine jaw model
Asia Medical Device Laboratory needed for cleaning validation testing on stainless steel implants. Before packaging, we will have an IPA ultrasonic cleaning to remove fine particles/dust and finger print. But we do not know how to validate this. So would like to check if your lab has experience in this?
Canada ISO FDA GLP Accredited Laboratory needed for GLP testing on bone like material, to meet the ISO 13485 requirement. looking for accredited lab (GLP) 10993-6, and 10993- 4, 10993- 5
USA Medical Device Product Safety Laboratory needed for USP Functionality testing with modification: USP<381> Functionality Tests: Self-sealing (n=575); and Fragmentation (n=575)
Product Safety Laboratory needed for anti-retroviral testing: Intravaginal ring containing antiretroviral compounds. Condom Compatibility testing to include the following: 1. air burst pressure and volume 2. tensile strength 3. viral particle penetration
US FDA GMP laboratory needed for Quality Control . testing for color test Capable of running a color test using a colorquest xe or equivalent instrument
USA FDA cGMP Microbiology Laboratory needed for CLSI Metho M40-A, Bacteriostasis Testing in Microbiological Transport Devices Testing ability of C&S and Cary Blair medium to maintain inocula at +/- 2 log using specific organisms in the presence of fecal matrix: Enterococcus faecalis, Escherichia coli, Shigella dysenteriae, Pseudomonas aeruginosa, Salmonella enterica, Vibrio parahaemolyticus, Clostridium difficile, Campylobacter jejuni, Staphylococcus aureus, Bacillus subtilis. Plate count after 0, 72, 96 and 120 hours at 25°C and 4-8°C. Also test recovery on swabs.
Blood Glucose Monitoring Meter Manufacturer Requests for Quotation from FDA cGMP Microbiology Laboratories for Virucial Efficacy Testing: *One Test Virus - Duck Hepatitis B virus as a surrogate for Human Hepatitis B virus *7 different test materials to be provided by the manufacturer *3 different disinfecting wipes to be provided by the sponsor
Dental Alloy Manufacturer needs GLP and FDA accredited laboratory for subcronic toxicity test (according to ISO 10993-11). This test has to be performed by a GLP and FDA accredited laboratory aiming to obtain CFDA registration in China and also the Taiwan registration. Test methods comply with the requirements of ISO 10993-11 :2006, and the report content is integrity. In particular, the experimental animals and the drug delivery cycle are need to meet with the requirements of ISO 10993-11 :2006 . So our target is not only CE marking, in fact our products are already CE marked. We would like to receive your most time/cost efficient quotation
Medical Device Manufacturer needs preclinical contract research organization for ISO Biological Evaluation of "Pressure Monitoring Kits". Tests to be perform as per- ISO 10993(External communicating device/Blood path, indirect/Limited duration) -Cytotoxicity -Sensitization -Irritation or Intracutaneous reactivity -Acute systemic toxicity -Pyrogenicity -Hemocompatibility Pls address:
USA Product Safety Laboratory needed for ANSI / AAMI Testing of table-top steam sterilizer to be tested according to ANSI/AAMI ST55
USA FDA GLP Biochemical laboratory needed for Solid state and chemical analysis of particulates using Raman spectroscopy.
Biomechanical Laboratory needed for dental implant testing: SEM of a clean and sterile titanium dental implant surface to document absence of particles from manufacturing process. This documentation is necessary for FDA clearance. We will provide 3 samples and we need couple of views from each sample.
USA Biomedical Laboratory needed for medical device testing: Biocompatibility testing, preservative efficacy testing, condom compatibilty testing, Biocompatibilty compliant with ISO 10993 to include acute systemic toxicity, vaginal irritation, sensitization and cytotoxicity. Preservative efficacy USP 36, condom compatibility ASTM D7661-10. Testing required for the submission of a premarket notification (510(k)) to FDA for a personal lubricant.
Medical Device Manufacturer needs Medical Comliance Lab for ISO Compliance testing service per ISO 27186 (section 4.3.9 Corrosion/environmental) for our new product, an implantable connector for pulse generator or defibrillator.
Medical Technology Laboratory needed for ANSI / AAMI Testing: disposable medical electrode testing to ANSI/AAMI EC12.
Large healthcare company needs clinical laboratory for blood testing: bioanalytical testing using blood per CLSI EP25-A, EP17-A, EP9-A2, EP05-A2, EP06-A, EP07-A2.
Physical Chemistry Laboratory needed for Nuclear Magnetic Resonance Testing on compound ordered from organic synthesis company (p - carboxybenzenediazonium tetrafluoroborate, CAS# 456-25-7) from an international organic synthesis company a
Microbiology Laboratory needed for pyrogen endotoxin testing. Please provide a quote.
USA certified laboratory needed for Product safety testing of our heat packs (used to treat body aches and pains)
FDA GLP Contract Research Organization CRO needed for FDA GLP Study: Biocompatibility Testing Name of testing: Modified Draize-95 Test Testing Description: The purpose of this test is to evaluate whether residual chemical additives at the level that may induce Type IV allergy in the unsensitized general user population are present in a finished natural rubber (NR) containing medical device.
Test Subject: Human
Medical Device Laboratory needed for Dental Ceramics Testing. We need 3 samples of ceramic zirconia tested for porosimetry by mercury intrusion, porosity by nitrogen and include the surface area (BET).
Electrical Laboratory needed for Electrical testing according to ANSI/AAMI EC 53 of leadwires for ECG electrodes. (Dielectric strength, noise testing,...)
Analytical Chemistry laboratory needed for contract synthesis: synthesize diazonium salts. The procedure is as follow: "4-Aminobenzoic acid, obtained from Alfa Aesar, (6.85 g, 50 mmol) was dissolved in 36.25 ml of 48% fluoroboric acid, obtained from BDH, (200 mmol) and 50 mL water. The solution was heated until all the solids dissolved completely and was then cooled in an ice water bath. Sodium nitrite, from Alfa Aesar, (3.65 g, 53 mmol) dissolved in 10 mL water was added dropwise to the reaction mixture with stirring. The solution was allowed to warm to room temperature and was concentrated by rotary evaporation to approximately half the original volume. The concentrated solution was cooled in an ice bath, and the resultant white solid was filtered and washed with cold ether and cold water, and dried in a vacuum oven. "
South America Analytical Chemistry Laboratory needed for chemical analysis of samples of methanol and acetonitrile Please send quotation for laboratory analysis of samples of methanol and acetonitrile
ISO Netherlands Microbiology Laboratory needed for microbiology testing : On site environmental monitoring for viable counts in clean room"
Biomedical Laboratory needed for extraction testing on Polyurethane gel adhesive strips to test for human skin contact safety and contaninates
Bioanalytical Laboratory needed for ISO biocompatibility testing to ISO 10993-1 of our surgical materials as per ISO 10993-1
European Union Microbiology Laboratory needed for Endotoxin Testing: LAL Testing (Bacterial Endotoxin Test ) & Rabbit Pyrogen Test for our Infusion/ Transfusion Set(medical Devices) Test Reference: As per USP Chapter 85 & 151 Note: The test Shall be conducted at any laboratory from European Union Countries. let us provide testing charge for LAL Test & Rabbit Pyrogen Test (03 tests each) if you have testing facility
Experienced California physical laboratory needed for multi-axis, multi-measurement head vibration analysis to find root cause of unacceptable vibration on some of our devices
Medical Device Laboratory needed for ASTM Testing and ISO Testing of medical devices: Biocompatibility testing,ETO Residual testing and Packaging validation testing 1-Biocompatibility of medical devices products (Syringes,blood lines ,......) to (ISO 10993-5)2 2- ETO Residual Test of the medical devices to (ISO 10993-7)3 3- Packaging validation for Peel pack (Paper) and PE pack ISO 11607 Part-1:2006 ISO 11607 Part-2:2006 BS EN 868 Part 1 BS EN 868 Part 5 ISO 11138 Part-1 ASTM F 1929-98:2004 ASTM F 1886/F 1886-09:2009 ASTM F 1140-00
Dentist from Dental Lab needed for medical product safety testing quality testing: Verification Testing of zirconia from China to see if is good quality Good strengh and safe in the mouth.
UK Microbiology Laboratory needed for dust drum microbial challenge testing of packaging for Orthopaedic implant
Research and Development Contract Research Organization for product development of a new pharmaceuticals transdermal patch. Our company is seeking initial product and prototype development.
Packaging Laboratory needed for EN - ISO Transportation Study: packaging validation testing against (Transportation/ distribution Testing) Our products consist of film and paper sealed on site (produced by our company), we need to know the efficiency of our packaging.
For any clarification and more info. Please do not hesitate to contact me.
Thanks for your usual support!
Medical Device Manufacturer needs Florida product safety, medical device laboratory for NFPA Testing and ASME Testing to ASME PVHO 1, Safety Standard for Pressure. Vessels for Human Occupancy and National Fire Protection Association NFPA 99, Healthcare Facilities Code. One sample - Soft hyperbaric chamber - No specialized shipping or handling required.
Microscopy and imaging non-destructive materials laboratory needed for Scanning Electron Microscopy (SEM) Analysis color SEM images? Is there any other technique which can provide color imagery at approximately 150/200x magnification? If so, what is the approximate price per hour or per samples and turnaround time for the testing?
Physical Laboratory needed for Ophthalmic instrument testing. Physical and/or organic chemist with experience with dyes such as gentian violet and indocyanine green to help us in our research.
Packaging laboratory needed for International Safe Transit Association ISTA Testing. Packaging/Shipping Testng to ISTA 2B, Preshipment Testing Procedures - Combination Tests for packaged-products weighing over 150 lbs. (68kg)
Contract Serology Lab needed for blood testing that can measure the level of soybean oil in blood
Medical Device Laboratory needed for mercury porosimetry testing to measure the porosity of UHMWPE samples with the method of mercury porosimetry?
Asia or US materials laboratories needed for ANSI Testing or EN388 Testing: cut level test on a glove that we import from China and wholesale to distributors. The confusion between ANSI and EN388 is incredible and I am caught in the middle.
US Toxicology Laboratory needed for Acute toxicity testing, Antibacterial testing and Chemistry testing
Preclinical Contract Research Organization CRO needed for preclinical studies: Cytotoxicity, Sensitization, Hemocompatibility. .
Medical Device Laboratory needed for validation study to validate EO sterilize 3 pallets of medical devices in one chamber What costs are associated with validation of the product through one fractional, 4 half and one full cycle?
Medical Device laboratory needed for ASM Testing to support FDA 510(k) of feminine hygiene products and are targeting markets worldwide recently. As for FDA 510(K) pre-market notification purpose, we seek for an agent who will do the condom test-ASTM D7661-10- with our product, personal lubricant. It would be appreciated if you share related information with us. - Expected cost / period - Related Process
Medical Device Product Safety Laboratory needed for nitrile examination glove testing. These tests will be used in support to our 510k submission to FDA for exam gloves with Low Dermatitis Potential claim.
? Modified Draize-95 Test ? Patch Test on Sensitized Individuals
Please provide us quote and lead time for these testing.
Materials Laboratory needed for ASTM testing and certification of the products according ASTM F-1674. Joint Restraint Products for Use with PVC Pipe 2. Can you test this kind of joint according the above mention standard? 3. If yes ? what more information you need? 4. In not ?
Orthpaedic Implant Manufacturer needs medical device laboratory for orthpaedic implant testing of finished products like bone screws, Bone plates, Interlocking nails, Hip Prosthesis, Clamps tested mechanically as per International standards. Kindly provide No. of samples required, Time duration and cost of testing.
Bioanalytical Laboratory needed for woundcare testing: amino acid analysis for amino acid composition/profile (including glycin, proline, hydroxiprolin, tyrosine and cysteine) in such a product. If so, I would appreciate it if you send me a price quote.
Clinical Laboratory needed for clinical study of dental stain blocker with effectiveness testing, safety testing
Medical Deice, Biomedical laboratory needed for ISO testing of implantable medical devices: biocompatibility testing to ISO 10993-1, Biological evaluation of medical devices 5 samples, orthopaedic implants
ASIA Laboratory needed for ASTM Testing of Lubricating Jelly to ASTM D7661, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
Southern USA FDA Registered and cGMP compliant laboratory needed for to perform ASTM D7661 testing to ASTM D7661, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms , compatibility, latex, lubricants, natural
Biochemistry Laboratory needed for Use of a microneedle rolling device to determine whether it affects melanin production.
FDA cGMP USA biomaterials laboratory needed for ASTM Testing of Bone Cement and control sample according to ASTM F451 for FDA compliance
United States medical device laboratory needed for medical device testing: ASTM Testing of the hydrophilic coating on a urology catheter to determine the Coefficient of friction as compared to other similar devices to Coated medical tubing ASTM D1894
FDA cMP, NABL medical device laboratory needed for ASTM testing: Coronary Stent and Balloon Cathether testing of Cobalt Chromium Coronary Stent System Testing. PTCA balloon Catheter Testing. Polymer Testing.
FDA cGMP Medical Device Laboratory needed for ASTM Testing to ASTM D3492. Declaration of conformance with consensus standards. For FDA approval we need the condom to be tested in all the respects with the requirements of the current edition of ASTM Standard Specifications for Rubber Contraceptives (Male Condoms), D3492
IV sets and IV extension sets manufacturer needs physical laboratory for IV testing: Tensile testing done to check the bond strength on the luer to tubing connections that we make here by a solvent bonding process.
USA or Asia FDA GMP Preclinical Laboratory needed for preclinical testing: nose filler - strontium hydroxyapatite 1. MTT assay on human epithelial fibroblast 2. in vivo testing on rabbit frontal sinus
Medical device manufacturer requires Canada or US Bioanalytical Laboratory for standardized, non-developmental testing methods for bioanalytical testing of bovine serum albumin powder for presence and concentration of total bovine IgG, IgG1 and IgG2, as well as fatty acids.
Europe, Japan, USA FDA GMP, ISO Biomedical laboratory needed for CE Marking and ISO testing of medical disposbles: disposable Respiratory function test, bacteria and Humidity Moisture Exchange(HME)filters. We want following parameters to be tested and certified. dead volume moisture output air resistance
FDA GMP Preclinical Laboratory needed for FDA Preclinical testing. Dental implants to be implanted in non-human primates in the mouth.
Biomaterials Laboratory needed for ASTM Testing: compatibility of non lubricated latex , poliurethane and polyisoprene condoms with a lubricant to ASTM D7661-10 : Standard test method for determining compatibility of personal lubricants with natural rubber latex condoms
Biomechanical laboratory needed for USP Testing: Biomaterial testing for properties of bio materials for sutures mechanical and biological tests as per USP standards for needles and sutures [knot pull, tensile stregth, straight pull, needle attachment, strength retention studies, penetration force, cross section, anti microbial coating test efficiency, throw test, elasticity] will provide samples and shipping.
FDA GMP Food Laboratory needed for food contact testing to FDA CFR 175.3 Resinous and polymeric coating testing that may be safely used as the food-contact surface of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with CFR 175.3
Asia electrical laboratory needed for IEC Testing: Determination of the halogen acid gas content in GRP/FRP(Fiberglass Reinfored Plastic) to IEC 60754-1
Microbiology Laboratory needed for anti-microbial testing of cold sterilizing solution by Immersion of medical equipment, formulated with glutaraldehyde to need to evaluate its antimicrobial properties, with elimination trials, especially bacterial spores, mycobacteria and viruses, with some international standards (ASTM, AOAC, EPA Test,). Initially i do the consultation about in wich laboratory can make this kind of test and if so what is the cost and requirements to perform.
Asia Medical Device Laboratory needed for ASTM Testing, ISO Testing, medical device testingto quantify the Stethoscope (medical device performance)- Sound Amplification and attenuation e.g. Frequency, Loudness(Decibel)
USA Biophysical Laboratory needed for ASTM Testing to ASTM F 2392-04 Standard Test for Burst Pressure Strength of Surgical Sealants.Need to evaluate surgical selants strength using the ASTM F 2392-04 Standard Test Method for Burst Pressure Strength of Surgical Sealants.
New Jersey biophysical laboratory needed for tensile testing. Lab to tensile test sample in the 25kN range. There are two conditions: 1. The lab needs to be in NJ. 2. I would like to be present during the test.
Contact Lenses Manufacturer needs medical device USA laboratory for physical testing and chemistry testing: Physi0chemical Testing for verification of the physico-chemical properties of materials - Test of exhaustive extraction (Soxhlet extractor) for at least 4 hours with a polar solvent (eg water) and a non-polar solvent (eg methanol) for each model of the lens - Test of spectral transmittance and rub test for adhesion. May you kindly recommend to us if there are laboratories in the USA.
Materials Laboratory needed for ASTM Testing to ASTM F640-12 radiopacity for a PP fibre filled with BASO4. diameter 152µm & 380µm
India Medical Device laboratory needed for medical device certification testing: certify Medical grade silicone products for implants and other uses(bottle nipple). Please send me the addresses and contact details of all labs that are approved by the Govt of india who can carry out such tests.
California FDA medical device aboratory needed for FDA certification testing of illuminating device used in sports type scopes. Need to certify if it's a LED device or class 1 laser as light source
PA, NY, NJ, FL, DE medical device laboratory needed for stability testing: shelf life testing of medical device wraps used with cooling system
Southern USA medical physical laboratory needed for ASTM Testing to ASTM F543. Insertion torque and pullout testing of 10 different styles of medical devices for orthopedics. 5 samples of each device (50 total).
Dental composite filling material manufacturer needs accredited laboratory for Biocompatiability Testing, PHysical Testing and EN ISO Testing EN ISO 4049:2009 standard procedure and also provide us the test result reports as they are also indicated in this standart. Test names: Polymerisation - Flexural Strength - Diametral Tensile Strength - Water Absorption - Biocompatibility? .
New Zealand FDA GMP materials laboratory needed for Solubility testing of ceramic (glass ceramic, surface area >30cm2) in acetic acid. We supply you the ceramic plate with specified surface area. Soak the ceramic plate, which is pri-dried at 150C for 4hrs, in 4vol% acetic acid (analytical grade), staying in oven 80C for 16hrs. After that, find out a weight loss by comparing the weights of the ceramic plate before and after soaking. The test procedure must follow Standard ANSI/ADA 69/ISO 6872:2008 Dental Ceramic, clause 7.6, specially 7.6.4 (our specimen is Type II. Please ignore the firing and glazing procedure specified in clause 184.108.40.206. The specimen is used as it is, but need to be washed and dried as 7.6.4) The test report will be used by us for FDA certificate application. Therefore, it is required that the test lab must be Ac
FDA GMP US analytical chemistry laboratory needed for plastics Extraction testing outlined by FDA 21CFR177.1520 and 21CFR176.170 for molded parts based on polypropylene.
FDA Medical Device Laboratory needed for Medical Device Testing of Intraloral Orthodontic appliances for long and short term use 1 clear acrylic disc 18mmx100mm
Analytical Chemistry Laboratory needed for nitrogen testing. Test the dew point of nitrogen of capacity plant 2NM3/hr. It is urgent pl provide contact details
USA biomedical laboratory needed for Validation Testing between two blood collection devices for hematology and common blood chemistry analytes.
Microbiology laboratory needed for ASTM Testing: Virucidal Testing to ASTM E1053 - 11 Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental SurfacesASTM E2362 - 09 Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection.
Large multinational medical device corp needs analytical chemistry laboratory for polymer testing: TGA testing with either FTIR or mass spec analysis of evolved gas to determine temperature for onset of HF generation.
United States biomedical laboratory needed for AAMI Testing of blood pressure transducers according to AAMI standard. The test will be performed to medical equipment
Asia Medical Device Laboratory needed for Catheter Testing: Mechanical Properties Testing as per FDA regulations for medical device registration. PTCA catheter in USA, could you give us some help about the product testing? the below is a guidance link about PTCA catheter. could you conduct the below test ? 9, Flexibility and Kink Test 10, torque test 12, coating integrity test 13, particulate test if you are able to conduct these tests, could you give me a quote and sample required and test protocol?
IS Medical Device Laboratory needed for CE Certification medical device stability testing: accelerated aging test for ETO Sterile Tyvek Pouch Packed Hydrophobic Intraocular Lens and also for Steam Sterile Tyvek Pouch Packed Hydrophilic Intraocular Lens
US FDA GLP bioanalytical laboratory needed for bioanalytical testing: capable of conducting aPTT (Activated Partial Thromboplastin Time) testing on wound dressing samples. GLP certification preferred.
ISO Materials Laboratory needed for ISO Materials Testing of medical device (hydroxyapatite)to ISO 13779-3 Implants for surgery Hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity for crystal characterization, purity and other chemical analysis in order to comply with ISO 13779-3.
ISTA Packaging Laboratory needed for International Safe Transit Association ISTA testing on the small packaging which is ISTA-3A, Pacaged - Products for Parcel Delivery Systems Shipment 70 kg or less ? Please specify the following: how much will you charge for the test? How many samples do you require? How long will the test take?
Europe Preclinical Toxicology Laboratory needed for Sensitization Testing , according to 11979-5, applied to intraocular lenses
Southern California Materials Laboratory needed for coating testing. Test light transmittance of a coating that is on a glass slide. We have 3 slides to be tested
Ireland Medical Device Laboratory needed for medical device testing. Develop a test method and carry out particulate testing of a minimally invasive catheter device. Approx. 100 per annum Carrying out the testing in a clean room standard Class 7 or Class 8 is an optional requirement.
FDA GLP Medical Device Laboratory needed for adhesive testing to evaluate physical properties of hydrocolloid adhesives - such as adhesive strength, removal force on human skin; preferably living human skin or a well-documented substitute
North America Microbiology or TOxicology Laboratory needed for disinfectant testing: hard surface disinfectant in development, requiring toxicology testing ("6-pack") for an EPA submission. It is a ready to use solution incorporating quats and low amounts of alcohol; common to existing formulations.
NABL Certification laboratory needed for NABL certification testing of R.O. Machine we require NABL Test Report to obtain SON Certificate. us know the procedure for obtaining the NABL Testing Report and the cost for the same.
FDA 510(k) CRO , FDA GMP Contract Research Organization needed for Medical Device Research and Development: Test Kit Manufacturing e are based in Washington and looking for a CRO who can handle 510(k) analytical studies and a 3 site trial on an MMRV multiplex based test.
We are ideally looking for a CRO who has their own laboratories or access to labs for testing work ahead of the final studies.
Ability to also manufacture test kits in a GMP/ISO13485 environment would be an advantage. "
Accredite USA Materials Laboratory Molded parts made of needle-Punched Nonwoven need to be tested to TL52662 material requirements."
Physical Laboratory needed for physical testing: ANSI Testing physical glove performance testing for cut, puncture, abrasion according to ANSI 105 - 2011.Hand Protection Selection Criteria International Safety Equipment Association
Toxicology, Bioanalytical and Environmental Laboratory needed for materials testing of face mask material for respirator with the characteristics of dustproof, antibiotics, and antipollution for protection from respiratory hazards, such as chemical and environmental hazards, as well as airborne biohazards.
California FDA GMP Laboratory needed for FDA impact testing to 21CFR801.410 impact testing Select 200 pcs random samples of sunglasses from 8200 pc lot in bonded Customs storage in Los Angeles. Conduct impact testing under 21CFR801.410 and report results. These are promotional sunglasses, to be given away as advertising. Supplier in China sent goods with fake testing docs and FDA is allowing us to correct
China medical device laboratory needed for testing dental implants according to SFDA standards,China SFDA Approval and Registration for Medical Devices
Eastern USA Medical Device Laboratory needed for Medical Device Testing of Hemostasis Valve Introducer Sheath. 1. Valve resistance to flow- Arterial pressure. 2. Durometer of dilator tube & sheath tube. 3. Hub/to tube pull test
USA Physical Chemistry laboratory needed for particle analysis: Quantitate particles, including silicone oil, present in prefilled syringes filled with water. measurements must be made using a brightwell Microflow imaging device (MFI).
India preclinical contract research organization needed for implantation and extractable testing of LDPE+BaSo4 as per 10993 and 12418 standard
UK Medical device laboratory needed for Biocompatibility testing for Class-III (EU Classification) personal lubricants.
"ISO Toxicology Laboratory needed for Toxicology testing of medical device with mucosa contact for 510k G95-1 compliance"
USA physical laboratory needed for Flow rate testing for tubing. We are developing tubing for use with a Vista pump and need to test the flow rates with the pump. We have both the pump and tubing avaliable.
USA ISO Laboratory needed for ISO Testing of Urine Collection Bag Testing as per ISO 8669 (Part 2),Urine Bags, Requirements and test methods.
Las Vegas Physical Laboratory needed for physical certification testing: drop ball testing for optical lenses 1.56 hard, AR coated lens
India toxicology laboratory needed for toxicology testing for Extractable & Leachable Study for rubber closures
Eastern USA Medical Device Laboratory needed for RoHS Testing: Test 17-4 Chrome Material for RoHS product certification. Need quote, number of samples required.....
Europe or UK plastics laboratory needed for PVC testing in PVC materials for medical device. Determination of: 1.Jellification degree2.K-Value3.Shore A hardness
USA Medical Device Laboratory needed for Blood collection set simulated-use testing for 510k. 10-20 phlebotomists needed to test safety feature of butterfly blood collection set in simulated patient use. Sample size 500 each.
Mechanical Laboratory needed for ASTM Testing for ASTM F1717 standard Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
USA bioanalytical laboratory needed for Coulometric Karl Fischer Moisture testing on human plasma products. (product is lyophilized)
Canada or USA Contract Research Oranization CRO needed for comparative in-vitro studies for BA and BE of spray device
Radiochemistry Laboratory needed for ASTM x-ray imaging of wound dressings incorporating radiopaque markers
Texas medical device laboratory needed for suture testing for the Tensile strength of four suture types (total of 160 samples)
Vienna, Budapest or Europe Medical Device Laboratory needed for medical device ASTM Testing to ASTM D4169, Distribution Cycle 13, Assurance Level = 2. Schedules A, C, F, E and A. Omit Schedules I (Tyvek lid) and J (double walled box). 8 boxes of medical devices 10.25" x 9.5" x 23"
USA physiological chemistry llaboratory needed for Measuring cellular energy parameters pre and post usage of a PEMF device which visibly rejuvenates skin. We want to determine what is happening at the organelle level. ATP, Ca++, electrical potential
Medical Device Preclinical Laboratory needed for implantation of a PMMA bone cement with bonded P32 radionuclide into the vetebrae and spinal canal of sheep or goat
Medical Device Research and Development Laboratory needed for prototype development / contract manufacture MEMS of either the cantilever or nanotube type
Medical Device Laboratory needed for ISO Testing to ISO 10555 - Sterile, single-use intravascular catheters for 510(k) submission
CClinical Laboratory needed for carrier testing for HBV,HIV(interfereing substances: minimum 50% whole blood) as per TG054 guidelines, Clause 6.4.5 (g)
UK medical device laboratory needed to Evaluate existing test data, conduct gap analysis, write assessement report using the requirements of ISO 10993 series as appropriate.
Large medical device manufacturer needs FDA GLP and GCP clinical Laboratory for Baclofen analysis in cerebral spinal fluid (CSF)
Medical Device Physical Laboratory needed for ASTM Testing: Burst Strength of Surgical Sealants according to ASTM F2392
USA or Europe FDA GMP electrical laboratory needed for FDA 510 (k) ANSI Testing, AAMI Testing and IEC Testing to IEC 80601-2-30:2009 ANSI/AAMI ES 60601-1:2005 IEC 60601-1-2:2007
FDA GMP Physical laboratory needed for dimensional verification, force to fire testing, material hardness, etc. The equipment required would be the likes of calipers, optical comparators, Instron/RAM/Zwick... The product is a firing assembly for an auto injector.
I'd be happy to talk through what we are looking for, you can call me (215)-259-3592.
USA Medical Device Laboratory needed for ASTM Test ing for latex on 4 different components: ASTM D6499 Inhibition ELISA
USA FAA aeronautical Laboratory needed for FAA Testing: AeroMedical device certification for airlines Portable ECG device for airplanes and other transportation needs EMI test for interference with NAV COM of airplanes during flight
Biopharmaceutical Medical device company needs materials laboratory with analytical method to quantify the oil and grease for our plunger springs of autoinjectors.
Microbiology Laboratory needed for anti-funal Testing of topical dressing for antifungal properties
India ISO Laboratory needed for ISO Testing to ISO 11979-3 4.1 General Requirements 4.2 Tolerances and Dimensions 4.3 Clearance analysis 4.12 Surface and Bulk Homogeneity 5.0 Recovery Properties Following Surgical Manipulation:
India ISO Laboratory needed for CE Mark Testing: Exhaustive Extraction Test per ISO 11979-5:2006, Para 5.2 and Annex A (3 lots; 1 solvent)
Leachables Test per ISO 11979-5:2006, Para 5.3 and Annex B (2 solvents)
Hydrolytic Stability Test per ISO 11979-5:2006, Para 5.4 and Annex C (temp tbd; two time points)
Photostability Test per ISO 11979-5:2006, Para 5.5 and Annex D
USA toxicology laboratory needed for toxicology testing on one of our dental polishes.
USA Materials Laboratory needed for random 30 samples from test material to EDANA 140.1 - Edana 140.1-81 - Air Permeability Recommended Test: Nonwovens Air Permeability
California UL certification laboratory needed for UL Certification testing: UL Field Label Test and Certification. 1 each Cellvizio® Confocal Endomicroscopy system for GI endoscopy, bronchoscopy and preclinical imaging.
Product Safety Laboratory needed for product safety testing of dental flossers, toothbrushes, dental mirrors, dental probes/picks (6 different products. Primary purpose of testing is consumer safety. Secondary purpose is product quality assurance/control. Essentially we would be needing physical testing to ensure that our products will not break when used, and also chemical testing to ensure that the materials used are in fact what they should be
Ireland and UK medical device laboratory needed for ISO Testing: Analysis of medical device materials. Compliance to ISO 8536-4 Infusion equipment for medical use
UKAS ISO Toxicology laboratory needed for 1 TEST - In Vitro Cytotoxicity to (BS EN 1SO 10993-5)
Eastern USA medical device laboratory needed for AAMI testing: Disposable ECG electrode testing per AAMI EC-12 and EC-53 ECG cables and leadwires
India medical device research and development laboratory needed for glucometer design
India Medical Device Laboratory needed for Medical Device Testing of critical medical devices
ISO 10993 -5
Irritation or intracutaneous reactivity
Systemic toxicity (acute)
Subacute and subchronic toxicity
ISO FDA GMP Laboratory needed for full-range in-vitro tests for contact lens physiochemical tests for contact lens eg Oxygen permeability, water content, extractable tests exclude biocompatibility tests