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Title:
Ventilator Testing
Description:
Medical Device Laboratory needed for ISO Testing on apparatus used on ventilator according to ISO 5356-1 Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets
Requirements:
Please let us know how long it will take
Title:
Medical Device GLP Toxicokinetic Studies
Description:
FDA GLP Certified Toxicology Laboratory is needed for medical device toxicokinetic study (for degradation products and leachables) according to ISO 10993-16.
Requirements:
GLP certification
Title:
Tests for Medical Device In Vitro Cytotoxicity.
Description:
ISO Certified Medical Device Product Safety Laboratory needed for ISO 10993-5: Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity.
Title:
Multi-Lab Precision Study of an In-Vitro Diagnostic
Description:
Three Bioanalytical Laboratory sites needed to conduct an in-vitro precision (repeatability and reproducibility) study of an IVD using banked serum samples that will be provided by the study sponsor. Each site will require three testers to evaluate 30 sam...
Title:
IEC Compliance of Medical Electrical Equipment
Description:
Electrical Laboratory needed for IEC compliance testing to IEC 60601-2-47 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
Requirements:
Link to the IEC Standard https://webstore.iec.ch/publication/2666
Title:
Medical Implant Cleaning Validation and Steam Sterilization
Description:
US FDA Medical Device Laboratory needed for cleaning validation and steam sterilization studies for medical implant and instrument set. Set is in rigid reusable three tray Sterilization case. Implants are titanium cages in a caddy. Hardest to clean dev...
Requirements:
US FDA cleaning and Sterilization requirements. Budget $5000. Terms must be Terms must be 50% down, 50 % upon completion net 30.
Title:
Implantable Medical Device Simulation
Description:
Medical Device Laboratory which has a MRI scanner needed for evaluation of implantable medical device.
Title:
ISO Contact Lenses Analysis
Description:
FDA GLP Medical Device Laboratory needed for ISO testing of soft contact lenses according to ISO 18369-3 Ophthalmic optics -- Measurement methods and ISO 18369-4 Physicochemical properties of contact lens materials
Requirements:
the test need to be GLP
Title:
EN Medical Device Evaluation
Description:
Medical Device Laboratory needed to perform testing as per EN 13544-2 (Respiratory therapy equipment. Tubing and connectors)
- A.3 Test method Resistance to gas flow of the tubing
- A.4 Method of test for security of connection between end connector an...
Title:
TB Assays Comparison Study
Description:
LONG-TERM TESTING Clinical Diagnostic laboratory needed that runs TB assays/tests to conduct a comparison study of TB sample processing methods. - samples would then be run on MGIT, LJ. Would also like to look at Xpert and LPA assays as well if available...
Title:
Tumorigenesis Study
Description:
Large Medical Device Company needed Toxicology Laboratory for Tumorigenesis Study according to Stem cell guidelines 2017 India and as per schedule Y or any other relevant guidelines) with nude mice.
Requirements:
na
Title:
Medical Device Biological Evaluation
Description:
Implantable Medical Device Manufacturer needs Product Safety Toxicology Laboratory for in vivo irritation testing as per ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization.
Requirements:
Please send quotation along with time frame.
Title:
ASTM Condom Compatiability
Description:
Medical Device Laboratory needed for ASTM Testing of personal lubricants for compatiability with natural rubber latex, polyurethane and synthetic condoms as per ASTM D7661-10. Standard Test Method for Determining Compatibility of Personal Lubricants with ...
Requirements:
ASTM D7661-10.
Title:
Surgical Gown Comparison Study
Description:
Large Organization needs Medical Device Laboratory for comparison study on 3 or 6 Surgical gowns suppliers testing against BS EN 13795 , including Wet Penetration , Dry Penetration, Mircobial cleanliness , particulant matter& linting , liquid penetration ...
Requirements:
We require the work to be completed by 16 April
Title:
Air Purifier Evaluation
Description:
PRODUCT DEVELOPMENT Microbiology Laboratory needed for particulate and virus/bacteria count from an air purifier to be manufactured
Title:
Leukocytes Analysis
Description:
Medical Device Laboratory needed for Clinical Study urine analysis for concentration of leukocytes. The following needs to be performed:
Negative urine is spiked with a specific concentration of Leukocytes
There are 9 concentrations of Leukocytes
30 ap...
Title:
ISO Medical Device IV Injection Testing
Description:
Medical device manufacturer seeking testing compliant with ISO 15747:2010, Plastic containers for intravenous injections relating to safe handling and the physical, chemical, and biological testing of plastic containers for parenterals. Please inquire fo...
Requirements:
ISO 15747: 2010, Plastic containers for intravenous injections.
Title:
Medical Device ASTM Packaging Testing
Description:
Packaging Laboratory needed for ASTM medical device testing to ASTM D4169 Distribution Cycle 12 Test (Shock/Drop, Compression, Vibration, Low Pressure and Impact testing)
The packaging is 500lb at 57 x 25 x 40
Requirements:
N/A
Title:
Optical Testing
Description:
Large Innovative Electronics Company needs Materials Laboratory for wavefront optical testing.
Title:
CCR Packaging Testing of Healthcare Caps and Jug Containers
Description:
Packaging Laboratory needed to perform testing to 16 CFR part 1700, Poison Prevention Packaging. Perform Test Protocol according to Canada Consumer Chemicals and Containers Regulations CCCR 2001 on our CR caps 38mm SAF IIIA with 3.78 L HDPE jug containe...
Requirements:
Deadline given is mid-March 2018.
Title:
Cleaning validation
Description:
Medical Technology Firm needs Medical Device Laboratory for validation assistance on two cleaning processes validations. We have already started the cleaning plans, but need some help to finalize them.
Title:
Toxicity of Menstrual Device
Description:
Medical Device Toxicology Laboratory needed for toxicity study testing for menstrual device.
Title:
Medical Device Biocompatibility Studies on Textile Products
Description:
Medical Device Laboratory needed for bio-compatibility studies on whitened cotton textile products including cytotoxicity test and primary skin irritation test
Description:
Medical Device Laboratory needed for ISO mechanical testing for joint simulator tests to ISO Standards ISO 14243, ISO 14242, ISO 18192
Description:
Performance Laboratory needed for failure testing to determine the max amount of weight a fabric foot restraint can hold.
Requirements:
max weight until failure.
Description:
Medical Device Laboratory needed for shelf life testing of clinical medical devices
Requirements:
Please provide quote
Description:
Medical Device Company needs FDA Laboratory for Washer/Disinfector Cleaning validations
Description:
Medical Device Company needs 3rd party Product Safety Laboratory for Biocompatiability testing (cyto, irritation, sensitization)
Requirements:
ISO standards
Description:
Medical Device Company needs Laboratory for cleaning validation testing to ISO standards.
Requirements:
ISO standards
Description:
Medical Device Laboratory needed for AAMI testing of for surgical gown to EN 868 part 2 for sterilization bag reel pouch
Description:
FDA GLP Product Safety Laboratory needed for biocompatibility testing for medical devices
Description:
Medical Device Manufacturer needs Contract Sterilizer for ETO and E-Beam sterilization experiments on materials used in medical devices.
Requirements:
discussion more
Description:
Large Medical Device Company needs Laboratory for transportation environmental simulation studies on sterile disposables to simulate distribution across the globe
Description:
FDA GLP Medical Device Product Safety Laboratory needed for ISO 10993-1 biocompatibility studies for implantable bone graft substitutes (granules), xenograft (from bovine bone) and a biphasic calcium phosphate Cytotoxicity- Sensitization- Irritation or...
Description:
FDA Contract Research Organization CRO needed for in vivo and in vitro studies of implant based bone cement medical device including material characterization and in vitro biocompatibility and osteogenic function and in vivo bone defect healing ability
Requirements:
They should be done according to FDA recoginzed standards such as 10993-1 and ASTM standards for implnats and medical devices.
Description:
USA Healthcare Manufacturer needs Microbiology Laboratory for bacterial analysis of r paraffin baths.
Description:
Microbiology Laboratory needed for virus penetration testing on latex condoms.
Description:
URGENT Genetics Laboratory needed for integrity study of the DNA structure of a virus and bacteria of a material after running through a medical machine
Requirements:
More details provided after NDA signed.
Description:
LONG-TERM TESTING Company seeks microbiology laboratory for certification testing on international standards of 3 medical disinfectant products for efficacy against bacteria (MRSA,TB etc.), virus (HCV, HBV, HAV, HIV, Rota, Adeno, Polio etc.) e.g.
Requirements:
Please provide the sample requirement, laboratory test charges or any other related cost.
Description:
Medical Device Laboratory needed for specification testing of #30 Dental Cements
Description:
Medical Device Laboratory needed for ASTM Testing of Protective Clothing to the following standards: ASTM F1670/F1670M Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood, ASTM F1671/ F1671M Stand...
Description:
Contract Sterilizer needed for ETO and E-Beam sterilization experiments on materials for medical devices.
Description:
Medical Device Laboratory needed for cleaning and validation studies to support our class II medical device 510(k) submissions to the FDA- will need to go over specific instructions for use, the level of disinfection and the type of microorganisms chosen ...
Requirements:
Need a lab that has experience providing this data to the FDA.
Description:
Medical Device Laboratory needed that that is knowledgeable of and able to test for requirements of ISO5367 and ISO5356 requirements for medical breathing components
Requirements:
Company to remain confidential
Description:
PRODUCT DEVELOPMENT Medical Device Laboratory needed for prototyping of a biomedical device (e.g. plaster, wound healing).
Requirements:
Ability to work with new materials to quickly develop a prototype device and measure basic properties
Description:
Medical Device Laboratory needed for sterilization procedure verification for an invasive tool with Autoclave Class B - ALARA type.
Requirements:
Please provide quote.
Description:
Medical Device Laboratory needed for testing of a filter developed for a medical application. The filter consists of a pleated element to trap particulates and a carbon-based filter to trap VOC's. The following testing is required:
1 - A trace showing...
Requirements:
Description:
URGENT Medical Device company needs preclinical Contract Research Organization for in-vivo surgical study of ECG data from a prototype cardiac monitor.
Requirements:
Initial test = 3 pigs, 150-200lbs/each, all simultaneously tested if possible, alternatively one tested immediately after the other. Initial test must be completed prior to December 15, 2017. Likely 10-20 more animal studies to follow. Possibly a chron...
Description:
FDA Certified Laboratory needed for FDA drop ball / lens impact testing of sunglasses to FDA 21 CFR 801.410 drop ball / lens impact test.
Requirements:
FDA certified test lab that is in direct contact with the FDA, familiar with eyewear and can conduct FDA 21 CFR 801.410 drop ball / lens impact test.
Description:
LONG-TERM SERVICES Contract Sterilizer needed for steam sterilization services for titanium medical devices, batches of 100-1000 peel-packs max 10 x 20 cm. ISO 13485
Autoclaves should comply with the requirements of, and be validated,
maintained and ch...
Description:
Healthcare Manufacturer needs materials laboratory which is capable of luminescence testing on afabric coated in photo-luminescent liquid. Laboratory must be able to test for luminescene in millicandelas over time.
Description:
START-UP Biomedical Imaging Laboratory needed for cadaver imaging & experimental testing focused on the computational biomedical engineering, involving imaging-based 3D virtual modeling & simulation
Requirements:
Please let us know the availability for phone meeting
Description:
LONG-TERM TESTING Medical Device Microbiology laboratory of Bioburden and sterility testing for implantable medical device. WE will send product for testing after sterilization using gamma radiation as the method of sterilization. 20 samples/ product fam...
Requirements:
support standard requirement.
Description:
FDA Medical Device Laboratory needed for FDA testing required for 510k approval for contact lens case. Please see section 7 of this previously approved 510k for full scope of testing: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162869.pdf
Requirements:
Requirements can be found in Section 7: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162869.pdf
Description:
Medical Device Manufacturer needs biomechanical laboratory for ISO 10328 Lower limb prosthesis structural testing
Description:
Large Medical Device Manufacturer needs Third-Party Laboratory for performance testing of a room air cleaner for smoke and pollen.
Description:
Medical Device Manufacturer needs materials laboratory for grout analysis for reformulation purpose
Requirements:
IMPORTANT NOTE: Please provide quotation.
Description:
Healthcare manufacturer needs Microbiology Laboratory for Bacterial Suspension Testing using P. aeruginosa. Specifications are: Suspensions diluted to 10^-6 and 10^-7 in sterile saline, pour plated in 0.2 ml amounts in Trypticase Soy Agar and incubated ...
Description:
Medical Devices Laboratory needed for performance and microbiology testing of medical textiles to EN 13795: 2011 A1: 2013 including Tensile strength - dry and wet - EN 29073-3:1992 Burst strength - dry and wet - EN 13938-1Resistance to fluid penetratio...
Requirements:
Please provide the costs for each test and the testing in general for one kind of medical textile. And also could you tell me, how long do I need to wait for the test results?
Description:
Medical Device Laboratory needed for sterilization validation testing of surgical instruments.
Description:
Medical Device manufacturer needs Contract Sterilizer for gamma or e-beam sterilization of diamond dental burs
Description:
LONG-TERM SERVICES Medical device company needs contract sterilizer for gamma sterilization and packaging of plastic disposable petri dishes.
Description:
Medical Device company needs materials laboratory for comparison of two adhesives to determine similarities and differences between the two such as chemical constitution, curing, strength etc.
Requirements:
We would like a report/summary of chemical constitution, curing, strength etc. for a couple lots of adhesive
Description:
Medical device company needs FDA consultant for advising on the registration and classification of self diagnostic kits prior to manufacturing.
Description:
Medical Device company needs biomedical laboratory to run a number of tests using human blood pumped through a flow loop and assay for the concentration of a number of analytes that are spiked into the flow path.
Requirements:
Access to human blood, ability to construct a flow loop using a low shear stress pump (Watson Marlow), ability to conduct general laboratory procedures.
Description:
LONG-TERM Contract Sterilizer needed for gamma sterilization of medical devices starting at 300,000 units going to 1 million in a year
Description:
Medical Device laboratory needed for CE Mark biomechanical testing of silicone liners for lower limb prostheses (amputees) to
ISO Standard 10328:2006 mechanical tests (torsional testing - static testing)
Requirements:
Structural tests : static test under load
Structural tests : static rupture tests
Structural tests : cyclic tests
Torsional tests
Description:
Medical device laboratory needed for physical testing of transfusion sets to the physical requirements of ISO 1135-4, Transfusion equipment for medical use -- Part 4: Transfusion sets for single use, gravity feed
Description:
Medical Device laboratory needed for surgery simulation and functional testing of sterile surgical packs after sterilization including on:
- aged samples (2 years past used by date) for: appearance (noting any signs of discolouration)
- functionality (...
Requirements:
As there is a spinal needle we need someone who can simulate the actual use of the procedural pack in actual surgery.
Description:
Medical device laboratory needed for several ASTM tests on orthopedic implant components as per ASTM F382 Standard Specification and Test Method for Metallic Bone Plates ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws. r...
Requirements:
In case if you can perform these tests, request you kindly to provide the quotation and tentative timeline(s) to conduct the tests and get the test
Description:
MEDICAL DEVICE LABORATORY NEEDED FOR ISO TESTING OF RESUSCITATOR AS PER ISO 10651-4. LUNG VENTILATORS
Description:
Company interested in acquiring an analytical laboratory in Saudi Arabia for the testing for quality assurance, testing, inspection, and certification of Agrochemicals & Pesticides, Basic & Industrial Chemicals, Dyes & Detergents, Lubricants & Greases, N...
Requirements:
Testing of Products like to name few.
Description:
Medical device laboratory needed for drug compatiblity testing and testing of parenteral IV containers to ISO 15747:2010 which contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers f...
Requirements:
ISO 15747:2010
Description:
Medical Device Laboratory needed for conducting safety and efficacy study of ear candle which assists with ear wax removal. The study should show that the ear candles do not cause burns, do not produce a suction or vacuum in the ear and do not introduce...
Requirements:
None
Description:
FDA Medical device microbiology laboratory needed to perform multi-use testing assay on a liquid bandage medical device product. This assay is similar to USP51 testing and will use the 5 specified microbes, but it must have repetitious bioburdens applie...
Requirements:
Thorough protocol and FDA-ready documentation.
Description:
LONG-TERM TESTING University researcher needs medical device laboratory for oxygen Permeability testing of contact lenses
Requirements:
Do not know exact number of samples, but will be sending samples throughout the year. Would like to know the charge rate of such services (by batch, by hour, etc)
Description:
LONG-TERM TESTING FDA GLP textiles laboratory needed for testing to provide profilometry data on our fabric samples used in medical / performance clothing products. We are interested in determining if this analysis could help us quantify texture between ...
Requirements:
GLP. Please send me a quotation for a sample analysis.
Description:
Medical Device company needs medical cath laboratory for in-vivo medical device acute physician training session
Requirements:
MUST have a cath lab (C-arms will not work), large sheep (70-80kg) required., 1-day, 12-15 people,
Description:
FDA compliant laboratory needed for a one-cycle Steam Sterilization Validation Study for a medical device
Requirements:
FDA Compliant
One cycle
Gravity Displacement
Description:
FDA Medical Device Laboratory needed for ISO VOC, particulate, CO and CO2 testing for ventilator components with dry gas pathway contact for emergency and transport ventilator to ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation ...
Requirements:
ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Description:
FDA GLP Medical Device Laboratory needed for performance testing of medical resuscitator to ISO 10651-4 Manual Resuscitator. The test to be performed include:
Delivered O2 concentration
- Expiratory resistance
- Inspiratory resistance
- Patient val...
Requirements:
-
Description:
LONG-TERM TESTING Medical Device Laboratory needed for dynamic fatigue testing of endosseous dental implants to ISO 14801
Description:
Medical Device Laboratory needed for medical device testing of after Ehylene Oxide Sterilization for MEA, HSSA (and possibly LAL) .
Requirements:
Our manufacturing and sterilization processes are located in Europe, so we would prefer if the laboratory testing would also be performed as close as possible (so somewhere in Europe, but others are not excluded).
Description:
Medical device laboratory needed for cleaning validation study of the water cleaning cycle of a plastic covered electronic tracking device . Simulation of the a 150C temperature water cleaning cycle for 30 minutes over a 500 cycles tis needed to ensure t...
Description:
Medical Device laboratory needed for several microbiology and toxicology tests of a polypropylene orthodontic device.
o Mercury limits
o Microbial limit test
o Toxicology assessment
o RIPT assessment (for products that touch skin)
o Pla...
Requirements:
Please provide the costs with your response.
Description:
Medical Device laboratory needed for ISO pre-compliance filter testing on medical ventilation module in accordance with ISO 23328-1:2008 standard, Breathing system filters for anaesthetic and respiratory use -- Part 1: Salt test method to assess filtratio...
Requirements:
Please provide costs of performing the test.
Description:
Medical electrical laboratory needed for IEC testing of sterile electrosurgical products to IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-2-2 Particular requirements for...
Description:
Medical Device Laboratory needed for stability testing of medical implantable balloon in PBS solution at 37 degrees incubation with 200 grams weight for 1 hour per day. Daily testing needed.
Description:
FDA GMP medical device laboratory needed for testing to support FDA 510(k) based on FDA-recognized consensus standards: 3-80 AAMI ANSI ISO 81060-1:2007/(R)2013 - Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Meas...
Requirements:
Purpose: FDA 510(k) Medical Device Premarket Notification
Description:
Medical device laboratory needed for surface topography imaging of titanium (machined and 3D-printed) spinal implants and surgical instruments including measurement of relative features and pore size.
Requirements:
Not used in FDA submission or quality related documentation. Images are for engineering evaluation and marketing purposes. I am not sure which imaging modality would best meet our needs and would like to set up a time to talk with a representative to bet...
Description:
Medical device microbiology laboratory needed for sterility testing of various medical device sets.
Description:
LONG-TERM TESTING Medical Device Laboratory needed for sterility test method validation and then routine sterility testing of medical device components per ISO requirements.
Requirements:
Per ISO requirements
Description:
Medical device laboratory needed for ISO testing of blue light and UV ray blocking optical lenses including ISO 8980-3, Ophthalmic Optics - Uncut Finished Spectacle Lenses - Part 3 Transmittance Specification and Test Methods.
ISO 14889, Ophthalmic Op...
Description:
Medical Device company needs packaging laboratory for transportation simulation studies of polypropylene and polyethylene medical devices with a shelf life of 5 years.
Description:
ISO 17025 medical device laboratory needed for full VDmax25 sterilization validation on titanium orthopedic screws to ISO 11137 including bioburden validation (correction factor), bioburden determination on three lots of product, delivering the verificati...
Requirements:
Test house to be ISO 17025 certified. All testing to be conducted in accordance with ISO 11137.
Description:
Medical Device laboratory needed for passive ligating clip medical implant testing to several ISO and IEC standards including:
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Env...
Requirements:
We need to carry out all the tests on a medical device - Ligating Clip
Description:
Performance laboratory needed for furniture life-cycle testing of seat back recline latch used as a medical device accessory to a wheelchair mechanism cycle test for 20,000 cycles.
Description:
Virology laboratory needed for virus transfer study of medical device membrane blood filter.
Requirements:
I am not aware of any current standards for this type of testing. However, the water filter treatment industry may have standards that might be applicable.
Description:
FDA GMP Medical Device Laboratory needed for ASTM testing of surgical gowns for compliance to ASTM D737-04 (2016) Air Permeability.
Requirements:
Needed for filing of FDA 510k
Description:
Medical Device Laboratory needed for ASTM testing of condoms to ASTM D7661-10, Standard Test Method For Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
Description:
Medical device laboratory needed for biocompatibility testing of long term orthopedic implants to ISO 10993-1 (Biological Evaluation of Medical Devices)
Description:
Medical device laboratory needed for physical ASTM testing of a range of titanium surgical-grade products to the following ASTM Standards: ASTM F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magneti...
Description:
ISO and FDA cGMP Medical Device Laboratory needed for validation study of the cleaning, disinfection (manual and automated), and sterilization of medical devices including bioburden, sterility, endotoxins, validation of sterilization procedures, and valid...
Requirements:
FDA approved, ISO approved, CE approved.
Description:
Orthopedics medical device laboratory needed for physical certification testing of prosthetic devices to ISO10328 (Prosthetics - Structural) for a lower limb prosthesis
Requirements:
ISO10328
Description:
Medical Device Laboratory needed for microbiology and physical testing of medical drapes and surgical gowns to several EN ISO standards:
1. EN ISO 22612 Resistance to Microbial Penetration - Dry,
2. EN ISO 22610 Resistance to Microbial...
Description:
Medical device laboratory needed for biodegradability testing on two different types of medical gloves to ASTM D5511 - Standard Test Method for Determining Anaerobic Biodegradation of Plastic Materials Under High-Solids Anaerobic-Digestion Conditions
Requirements:
Comparison of two different glove types in terms of biodegradability
Description:
FDA cGMP Medical device laboratory needed for product safety and toxicology study testing of water based personal lubricant including
1) Condom biocompatibility
2) Systemic toxicity
3) Vaginal irritation
4) Dermal sensitization
Requirements:
For FDA medical device 510K application.
Description:
Medical Device laboratory needed for physiochemical testing including thermal, mechanical and dynamic analysis to support the development of a new transdermal patch. Studies to include rheology measurements on native adhesive and the drug-in-adhesive form...
Description:
Large pharmaceutical and medical device company needs bioanalytical laboratory for a study using reverse transcription-polymerase chain reaction (RT-PCR) to determine permeability resistance of a dyalizer membrane to Hepatitis C.
Description:
FDA cGMP medical device laboratory needed for condom biocompatibility testing in accordance to FDA guidelines.
Description:
Large company needs medical device laboratory needed for ASTM testing of 4 orthopedic products including metallic medical bone screws, metallic angled orthopedic fracture fixation device, external skeletal fixation device, and metallic bone plates to ASTM...
Requirements:
1. ASTM F543 Annex A1, A2, A3 (Metallic medical bone screws),
2. ASTM F384 Annex A1, A2 (Metallic angled orthopedic fracture fixation devices),
3. ASTM F1541 Annex A5 (External skeletal fixation devices),
4. ASTM F382 Annex A1, A2 (Metallic bone plates...
Description:
Laboratory needed for waterproof testing of medical alert device to International Electrotechnical Commission (IEC) IP code rating IPX6.
Requirements:
Not sure
Description:
Medical device / materials laboratory needed for ASTM testing of personal protective equipment / gloves to ASTMF2878-10 (Needle Stick Test)
Description:
Microbiology laboratory needed for medical device disinfectants virucidal efficacy testing to the following:
MDD 93/42/EEC Class IIB) according to EN 14476:2015 Virucidal Efficacy Test and EN 17111:2017 Virucidal Activity Test.
Description:
Polymer laboratory needed to identify composition of a gelatinous elastomer product and a coating product used for breast prostheses and other medical applications. The elastomer consists of polymer pellets and medical grade mineral oil.
Requirements:
No testing standards required, just identification of composition of both products.
Description:
LONG-TERM TESTING Medical device materials laboratory needed for ASTM testing: active Af temperature of wire using DSC per ASTM F2004, Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
Requirements:
Able to carry out DSC testing on wires according to ASTM F2004.
Description:
Biomechanical / medical device laboratory needed for development of spinal implantable device manufactured with implantable grade PEEK and Titanium 3. The following testing is required:
1. Slippage test - the implant spikes or serration should be strong...
Requirements:
I will also request you to please send us the approx testing charges and time required for the tests.
This implant will in titanium and peek material. The job of these implants will be to maintain the space between the two bones. These implants will be...
Description:
FDA / GLP certified and AAALAC registered medical device Contract Research Organization CRO needed for preclinical in vivo thrombogenicity study of implantable cardiovascular catheter
Requirements:
Implanting the catheter into the canine blood vessel (juglar/ femoral/ vena cava) for 4 hours.
For EU/JP submission, we would like for CRO to administrate the heparinized saline at the clinical dose and to measure ACT level under GLP control. We are sear...
Description:
Medical Device company needs physical chemistry laboratory for surface tension and surface energy testing
Description:
FDA cGMP consumer products laboratory needed for impact resistance testing of sunglass lenses to (21 CFR 801.410(d)(1) f300 unit test
Requirements:
https://www.fda.gov/downloads/ScienceResearch/FieldScience/LaboratoryManual/UCM092191.pdf
Guidance for Industry and FDA Staff Impact Resistance Lenses: Questions and Answers
Description:
Bioanalytical laboratory needed for analytical chemistry and microbiology testing to support stability extension of hydrolyzed collagen used in medical devices including viscosity, clarity, color, ash, moisture, pH, SO2, chromium, lead, heavy metals, PCP,...
Requirements:
Need testing for viscosity, clarity, color, ash, moisture, pH, SO2, Chromium, Lead, Heavy Metals, PCP, Fluoride, Protein, Bulk Density, Total Bacterial Count, Salmonella, E. Coli
Description:
ISO 17025 medical device laboratory needed for cleaning / sterilization validation testing on bone fixture medical devices.
Requirements:
Dallas preferred, but open to anywhere in Texas.
Description:
Medical device safety laboratory needed for biocompatibility testing of medical devices.
Description:
Medical device microbiology laboratory needed for USP sterility and endotoxin testing of a pre-assembled medical kit including: gauze, syringe, scissors, medical thread for stitches, etc
Requirements:
Laboratory must be in Canada.
(Pre-assembled medical kit including: gauze, syringe, scissors, medical thread for stitches, etc).
Description:
Medical device laboratory needed for acoustical testing of ultrasound gel for sound velocity, acoustic impedance, and sound attenuation.. Please provide price quote.
Requirements:
Sound velocity, acoustic impedance and sound attenuation.
Description:
Medical device laboratory needed for light safety testing of an opthalmic instrument according to ISO 15004.
Requirements:
India laboratory preferred
ISO 15004 Ophthalmic Instruments- General requirements and test method
Description:
Packaging Laboratory needed for medical device package design qualification testing of a UN 4G fiberboard box
and 47 x 40 x 1.5-mil poly red bag with twist tie and knotted closure.
Requirements:
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...
Description:
Medical Device Laboratory needed for Acoustics and Bench Testing: Sound Velocity, Acoustic Impedence, Sound Attenuation; Physical Measurements: Viscosity, and Density of ultrasound gel
Description:
FDA GLP ISO-17025 bioanalytical laboratory needed for characterization of collagen scaffold medical device including amino acid analysis, quantification of Collagen I, DNA, GAG, lipids, protein assay, trypsin resistance, residue analysis, and hydroxyproli...
Requirements:
Operating under GLP. Prefer ISO 17025 certified.
Description:
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 c...
Description:
Medical Device Manufacturer needs bioanalytical laboratory needed for USP particle analysis on samples taken from medical device. Please provide quote on samples taken from the device.
Description:
Medical Device laboratory needed for a cleaning validation study of a medical device. Validating manual cleaning and detergent type cleaning: chemical-detergent with enzyme.
Requirements:
Cleaning validation study, manual cleaning, detergent type: chemical-detergent with enzyme
Description:
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-...
Requirements:
If possible/necessary FDA approval or some established equivalent, toxicology reports, human exposure limits (oral, dermal, inhaled).
I would like immediate feedback in regards to my potential options, but would like all/most data collected and communi...
Description:
FDA GMP medical device microbiology laboratory needed for
antimicrobial efficacy testing of a wound dressing complying to FDA standards.
Requirements:
All testing to comply with FDA requirements for regulatory submission
Description:
Pharmaceutical medical device laboratory needed for sperm motility testing of a personal lubricant according to ISO 10993-10.
Requirements:
Once testing is complete, I need a report I can submit with my 510K application. Preferably, there is a test method under ISO 10993-10.
The regulation number assigned to this device is 884.5300.
Description:
LONG TERM TESTING Medical Device Company needs laboratory for dry He mass spectrometer leak detection testing with minimum sensitivity 0f 5x10 to the -10.
Requirements:
minimum sensitivity 0f 5x10 to the -10
Description:
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) Impuritie...
Requirements:
All of these tests would be performed on samples collected with/without infusion through medical device.
We plan to collect samples at our company and ship to you for analysis (assuming we don?t have storage stability issues).
Description:
RAPID TURN AROUND NEEDED. Microbiology laboratory needed for efficacy testing of a disinfectant used for sterilizing medical equipment. Quote needed.
Requirements:
Efficacy Testing and fast turn around result.
Based on our internal study/test, we were able to achieve a Log 3 reduction using Log 3 stripes.
Description:
Medical device laboratory needed for cleaning and steam sterilization validation testing of a reusable medical implant completed on on a Scan Adapter (scan abutment).
Requirements:
Looking to initially sell this product in the US, EU, CAN, and AU (as I know there are different regulations we must follow).
URGENT quote needed.
Description:
Medical Device company needs materials laboratory for mirror testing for reflectivity in the spectra range 600 nm - 1100 nm.
Requirements:
India preferred.
Description:
GLP medical device laboratory needed for gamma sterilisation validation testing of a dental implant, and shelf life testing of implant packaged in ultra-high-molecular-weight polyethylene with healing screw packaged in polystyrene.
Requirements:
GLP certified lab
Need the test reports for FDA 510k Submission
Description:
FDA GLP Product Safety Laboratory needed for Biocompatibility Testing for a medical device according to ISO 10993-1. Specifically Cytotoxicity testing (ISO 10993-5) and Irritation and Sensitization testing (ISO 10993-10).
Requirements:
GLP
Description:
FDA GLP Medical Technology laboratory needed for medical device testing for Characterization of mechanical properties.
Requirements:
Must comply with the FDA requirements for Good Laboratory Practice
Description:
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 BENDI...
Requirements:
ISO 5367
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
Description:
Medical devices laboratory needed for testing a medical plaster bandage according to Medical Devices Directive 93/42/EEC Annex VII for approval of European Conformity (CE) marking.
Requirements:
Medical Devices Directive 93/42/EEC Annex VII
Description:
Medical device laboratory needed for permeability testing of different fabrics for patient comfort.
Requirements:
Permeability
Breath-ability
Description:
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 Lubrica...
Requirements:
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 vit...
Description:
Radiochemistry laboratory needed for medical imaging certification testing of X-ray imaging machine.
Description:
Medical device laboratory needed for validation testing of endoscopy instruments.
Description:
FDA GLP medical device preclinical laboratory needed for product safety testing of biodegradable implant for biocompatibility and cytotoxicity according to ISO 10993-5:2016 standards.
Requirements:
Biocompatibility / cytotoxicity items, according to ISO 10993-5:2016 for an permanent biodegradable implant in contact with the blood circulation.
Description:
Analytical laboratory needed for testing medical devices.
Description:
Medical Device Laboratory for medical equipment verification testing of wheelchair, bed alarm sensor, and lift chair according to specifications.
Requirements:
Description:
LONG TERM TESTING: NABL and ISO/IEC 17025:2005.laboratory needed for osmolarity testing of personal lubricants
Requirements:
NABL, ISO/IEC 17025:2005, Osmolality
Description:
FDA GLP laboratoryneeded for vendor qualitificaiton testing of surgical drapesL Resistance to microbial penetration - dry and wet, Cleanliness-microbial, particulate matter, Linting Resistance to liquid penetration, Burst strength-dry, wet, Tensile stren...
Description:
Orthopedics Medical Device Laboratory needed for ASTM Biophysical Testing: static compression, compression sheer, subsidence, dynamic compression, fatigue to runout, cantilever bend, dynamic cantilever bend
Description:
Personalcare company needs medical device laboratory for Health Canada Class ii tampon compliance testing prior to importation into Canada.
Description:
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 s...
Requirements:
We would like the contact information and company to remain Confidential.
Description:
Medical device company needs Electromyogram (EMG) done for small muscle activity related to eye movements.
Requirements:
Sensitive EMG equipment for small muscle activity
Description:
Pre-clinical research laboratory with surgical capabilities needed to conduct ENT procedures on chinchillas to test a medical device.
Requirements:
GLP standard
Chinchillas (at least 21), adults
Surgery room suitable for ENT procedures
Description:
Laboratory needed for PHMB quantification and full assay tests for contact lens multipurpose solution
Requirements:
PHMB quantification and full assay tests for contact lens multipurpose solution
Description:
UK Medical device company needs paper surgical adhesive tapes tested
Requirements:
tests required:
1. adhesion to steel
2. self- stick adhesion.
3. weight of backing material
4. weight of adhesive mass
5. minimum breaking load
Description:
Large medical company needs to test drug delivery of Taxol via small bore connections against chemical stress cracking per ISO 594-2, DIN 13276, DIN EN ISO 80369-1 standards
Description:
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 ...
Requirements:
all the testing are compliant for FDA 784 Guidance
Description:
Product Safety Laboratory needed for Toxicology Testing to ISO 10903-5,
SVHC
Substances forbidden in EU Legislation
Non-Cytotocic
Latex free
Requirements:
ISO 10993-5.
Description:
FDA Compliance testing needed for a low level disinfectant to be used on Class 1 (non critical) medical devices.
Requirements:
We are looking for laboratory services to test our disinfectant solution compatibility with specific materials and medical devices as per regulatory requirements.
Description:
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 valida...
Requirements:
Test includes 4 different products - 20 samples for sterility tests ( 10 aerobic+10 non-aerobic). Sterilization is done in Eastern Europe.The time between sterilization and start of the test not more than 72 hours and those should include transportation f...
Description:
Medical Device laboratory needed for Dental product testing of dental implants, abutments and surgical equipments. for drills- for radial run out, temperature rise during the drilling operation etc.
Description:
Medical Device Company needs Biomechanical Laboratory for ASTM / ISO medical device testing of orthotic that supports body part of patient having musculoskeletal injury. It is analogues to orthopedic cast.
Requirements:
We are looking for ASTM/ISO test results for our device.
Description:
Medical Device microbiology laboratory needed for SAE and USP Testing of Nonwoven and Fibers to USP 61 and 62.
2.)We will also need testing done for Smell and Fogging (SAE J 1756)
Requirements:
1.)Pathogenic Germ testing(Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Enterococcus).
2.)Smelling and Fogging Tests to the SAE J 1756 standard
Description:
ISO Accredited USA and European Biophysical Laboratory Needed for biomaterials testing of dental implant material: to ISO 14801- Dynamic fatigue test for endosseous dental implants
Requirements:
ISO 14801- Dynamic fatigue test for endosseous dental implants
Description:
Biomedical company needs biomaterials laboratory for ISO Testing of resins cements to ISO 5833:2002 specifications, Implants for surgery -- Acrylic resin cements
Requirements:
ISO 5833:2002 specifications, Implants for surgery -- Acrylic resin cements
Description:
ISO 17025 accredited laboratory needed for ISO Radioactivity testing of dental materials by the dental standards ISO 6872 by gamma spectroscopy.
Requirements:
Laboratory will need to have ISO 17025 accreditation to determine the activity concentration of 238U by neutron activation or gamma spectroscopy. Note: those with gamma spectroscopy techniques should be used to screen for adulteration.
Description:
Medical Device Manufacturer needs laboratory for cleanliness testing of medical electrodes.
Requirements:
Electrodes need to be tested for hygienic reasons. P
Description:
Non-GLP research laboratory needed for Optimization of real time PCR for diagnostics
Requirements:
without GLP
Description:
FDA registered Medical device laboratory needed for Residual solvent testing in Transdermal Patch
Requirements:
FDA registered
Description:
Genetics Laboratory needed for DNA and RNASE removal (cleaning) testing for disinfectants to remove DNA and RNASE
Description:
Electrical laboratory needed for electrical testing on new medical device prototype:
1.Ground Continuity test
2. High voltage test
3. Insulation Resistance test
4. Leakage current test
Description:
Medical Device Laboratory needed for toothbrush bristle testing for stiffness of toothbrush bristle
Requirements:
testing to be done by instrument TRIBOMETER
Description:
Medical Device Laboratory needed for quality control testing of sanitary pads for all quality parameters including physical measurements.
Requirements:
as said above
Description:
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...
Requirements:
We are not sure if we need microbiological testing, but our bands are not sterilized before use. Our devices contain colorants that may leach from them, but each product is only installed for < 4 weeks at a time.
Description:
Preclinical Bioanalytical laboratory needed for biological medical device testing: FGF2 and glycosaminoglycans content in small intestine submucosa medical device
Description:
Medical device laboratory needed for physical testing of gauze used to manufacture sterile wound dressings.
Requirements:
ability to conduct tests such as density and tensile strenght
Description:
Contract laboratory needed for test methods development for medical device/ drug combination product. Development of a drug degradation test method for stability. There are 2 API in medical device
Requirements:
there are 2 API in this device.
Description:
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 cuff...
Description:
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 Metho...
Description:
Contract Medical Device Laboratory needed to perform testing on Disposable Blood Pressure Transducers in accordance to ANSI/AAMI BP22.
Requirements:
Lab needs to be qualified and capable of performing ANSI/AAMI BP22 testing for Blood Pressure Transducers. Test scope includes mechanical and electrical requirements as specified in the standard. Location of the lab can be in USA or Singapore.
Description:
Medical Device Product Safety Laboratory needed for ISO biocompatiability testing of tattoo inks tested by ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, in order to import them to ...
Description:
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 Conditioni...
Description:
Biomechanical laboratory needed for bone porosity testing measurements of bone samples
Requirements:
Any method used for bone porosity testing
Description:
Acoustics laboratory needed for ultrasound gel testing: sound velocity, acoustic impedance, sound attenuation. Please provide price quote.
Description:
Product Safety Laboratory needed for toxicology testing for ultrasound gel to ISO 10993 testing including cytotoxicity, sensitization and irritation ( categorized our product as a surface device, for intact skin with a limited contact duration).
Description:
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...
Requirements:
Description:
Therapeutics company needs laboratory for Syringe plunger force testing to ISO 7886-1 Annex G only
3 syringe models x 5 units/model x 3 reps/unit = 45 tests total
Description:
Medical device company needs virology laboratory for virus testing of surgical products Biologics
Description:
LONG-TERM TESTING Large Medical Device Company needs materials laboratory for RAL-GZ 387/1 compression testing for fabric
Description:
Medical Device Laboratory needed for testing to develop methods for airway obstruction / choking hazard analysis
Description:
ISO certified Medical Device Laboratory needed for Bio feedback system testing to 60601 CB Scheme. Possible FCC (and equivalent for EU, Japan, Brazil)
Requirements:
ISO Certified lab
Description:
Orthopedics company needs medical device product safety laboratory for accelerated ageing testing of Orthopaedic implants in tyvek pouches including extracables and leachable testing
Description:
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)...
Requirements:
Knowledge of microbiology and familiarity with medical device disinfection/cleaning.
Description:
Biomechanical Laboratory needed for Compression fatigue testing on dental implants under saline per ISO 14801, Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants
Requirements:
need to run 5 samples simultaneously which means that the testing facility should have at least 5 testing machines to conduct the testing on all five samples at the same time.
The testing facility is preferred to be in California but it is not mandat...
Description:
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...
Description:
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 spe...
Requirements:
ISO 594
Description:
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 (...
Requirements:
1) G-60 Mobile Control (0.97 mtr X 0.77 Mtr X 0.70 Mtr) 70 Kg. weight.
2) G-100 Mobile control (0.97 mtr X 0.77 Mtr X 0.70 Mtr) 70 Kg. weight.
3) G-100 FR Control (0.97 mtr X 0.77 Mtr X 0.70 Mtr) 80 Kg. Weight.
4) DX-300 Control (1.32 mtr X 0.87 mtr...
Description:
FDA GLP Europe preclinical contract research organization needed for GLP preclinical trial of biodegradable medical device .Animal trial with large animals (mini-Yucattan pigs)
Requirements:
GLP, to be used for FDA submission. European laboratories welcome to apply.
Description:
Medical Device manufacturer needs laboratory for accelerated shelf-life aging of medical products. 60 Samples. Laboratory must have oven with temperature control up to 60C and humidity control up to 90%.
Requirements:
Oven with temperature control up to 60C and humidity control up to 90%.
Description:
Medical device laboratory needed for chemical characterization testing of nylon surgical sutures for ISO1993 compliance.
Description:
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 sensiti...
Description:
Medical technology laboratory needed for ASTM Integrity Testing of balloon portion of enteral feeding devices as per ASTM F2528, Enteral Feeding Devices Retention Balloon Test Machine
Requirements:
The simulated gastric fluid should following the guidelines specified in ASTM F2528. The pH of the solution should be 1.2.
Description:
Physical Laboratory needed stress testing done on chiropractic table equipment
Description:
Medical technology laboratory needed for catheter testing on intravenous catheter throughout the indicated therapy to check on thrombosis and flow rate.
Description:
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 t...
Description:
Medical Technology / Biomedical laboratory needed for catheter testing: Embolic cube testing
Description:
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 tor...
Requirements:
¬
Description:
Medical Device laboratory for identification testing for the detection of cutting oil (mobilmet 766) on dental implants
Description:
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 Medic...
Requirements:
As per FDA requirements
1. Biocompatibility - 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 suppl...
Description:
Toxicology laboratory needed for in-vitro cytotoxicity testing of medical product. Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
Requirements:
EN 30993-5-ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
Description:
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 produc...
Requirements:
List of Viruses
1 African Swine Fever
2 Avian influenza
3 Adenovirus associated virus
4 Adenovirus Type 2,
5 Bovine Viral Diarrhea Virus (BVDV)
6 Canine Parainfluenza Virus
7 Canine Distemper virus
8 DNA pox virus
9 Enterovirus ...
Description:
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 me...
Description:
Medical devices manufacturer of FDA class I,Ila and III medical devices needs India NABL laboratory for biocompatiability studies
Requirements:
NABL. Please email or use communication through ContractLaboratory.com. No calls.
Description:
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.
Description:
Preclinical Laboratory needed for Biocompatibility Study for implant material SS 316L as per ISO 10993 , Biological evaluation of medical devices
Requirements:
Accreditation details of Laboratory
Description:
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 m...
Description:
Physical Laboratory needed for medical device vibration testing and physical impact testing of Titanium Osmotic Pump in Medical Devices
Description:
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...
Description:
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 testi...
Description:
Medical Device Laboratory needed for Residual ethylene oxide and ethylene chlorohydrin testing of medical devices in compliance with ISO 10993-7
Requirements:
GC and headspace analysis
Description:
Preclinical Medical Device Laboratory needed for Medical Devices Vibration testing, Medical Devices Impact, Medical Devices Electromagnetic Compatability Testing EMC Testing
Description:
Microbiology Laboratory needed for Microbiology Testing of Neurology Electrode Medical Devices
Description:
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 devic...
Description:
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 ...
Requirements:
ISO 10993-16:2010
Description:
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 Shippin...
Description:
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 stand...
Requirements:
Cytoxicity testing in line with ISO10993-5:2009Irritation and Sensitization in line with ISO10993-10:2010We would like our contact information and company name to remain confidential please.
Description:
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, complemen...
Requirements:
ISO, FDAcontact information and company to remain Confidential.Please, replay to my e-mail address, so I am aware of the fact that my request was accepted
Description:
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...
Requirements:
ISO, NABL, or ISTA
Description:
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
Requirements:
ASTM F1980
Description:
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 condu...
Description:
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 1099...
Requirements:
1- Biocompatibility (ISO 10993-5)2- ETO Residual (ISO 10993-7)3- Packaging validation (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 ...
Description:
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?
Description:
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
Description:
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).
Requirements:
ASTM F543
Description:
China medical device laboratory needed for testing dental implants according to SFDA standards,China SFDA Approval and Registration for Medical Devices
Requirements:
testing dental implants according to SFDA standards
Description:
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 ...
Requirements:
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)
Description:
India Medical Device Laboratory needed for Medical Device Testing of critical medical devices
Test
ISO Standard
Cytotoxicity
ISO 10993 -5
Sensitization
ISO 10993-10
Irritation or intracutaneous reactivi...
Description:
Malaysia, Singapore or India Materials Laboratory needed for ASTM Testing of Type-II Titanium Anodized surfaces of Medical devices to .ASTM G98 - 02(2009) Standard Test Method for Galling Resistance of Materials2.ASTM G195 - 08 Standard Guide for Conducti...
Requirements:
1.ASTM G98 - 02(2009) Standard Test Method for Galling Resistance of Materials2.ASTM G195 - 08 Standard Guide for Conducting Wear Tests Using a Rotary Platform, Double-Head Abrader3.ASTM G115 - 10 Standard Guide for Measuring and Reporting Friction Coeffi...
Description:
We are into design, manufacture and marketing of medical products that are used by healthcare establishments. We need FDA GLP and ISO Laboratory for biocompatibility tests for our medical product in your esteemed laboratory as per standard ISO 10993 (Biol...
Requirements:
FDA, GLP, ISO, .
Description:
FDA GLP Toxicology Laboratory needed for GLP Toxicology Testing Subacute (or subchronic) toxicity test on a dental restoration to ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' .
Requirements:
ISO 10993, GLP
Description:
Medical Device Laboratory needed for PMDA Testing (Pharmaceuticals and Medical Devices Agency, Japan) Performance Testing: \Performance measurements of diagnostic ultrasound as per Japanese Industrial Standard JIS T 1501:2005
two samples (two different...
Requirements:
PMDA (Pharmaceuticals and Medical Devices Agency, Japan) - Japanese equivalent of FDA Please keep confidential
Description:
Israel analytical chemistry laboratory needed for reverse engineering, deformulation testing for medical devices (denture cleaner powder)
Description:
FDA GLP Preclinical Laboratory needed for GLP Biocompatibility Testing of medical devices - limited contact with intact skin: - cytotoxicity Tests-ISO 10993-5 - sensitization Tests-ISO 10993-10 - irritation Tests-ISO 10993-10 and implant efect ISO 10993-6
Requirements:
21 CFR 807
Description:
Canada, USA FDA GLP Preclinical Contract Research Organization needed for GLP Biocompatiability Study: ASTM F719-8, Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation. (Biocompatibility)
AAMI / ANSI / ISO 10993-16:19...
Requirements:
GLP
Description:
Europe Transportation laboratory needed for ASTM or ISTA Testing : Transport simulation testing for medical devices in shipping cartons
Requirements:
ASTM D4169 or ISTA
Description:
India preclinical laboratory needed for biocompatibility testing for medical devices.
Description:
FDA GLP Preclinical Laboratory, CRO needed for ISO In-Vivo Testing of Medical Devices in vivo according to ISO 10993 (intradermal reactivity, acute toxicity, sensitization)
Requirements:
GLP
Description:
Transportation Laboratory needed for medical devices transportation testing, ie. packaging validation
Description:
USA GLP Medical Devices Laboratory needed for testing coefficient of friction with and without a medical device (personal lubricant)
Requirements:
GLP
Description:
ISO Medical Devices Laboratory needed for testing gloves - Material: 87% Polyamide, 13% Elastan as per ISO 10993-5 and ISO 10993-10.
Requirements:
ISO 10993-5: CYTOTOXICITY; ISO 10993-10: IRRITATION
Description:
ISO Medical Devices Laboratory needed for biological evaluation on Neoprene+polyamid+elastam as per ISO 10993-5 and ISO 10993-10.
Requirements:
ISO 10993-5: CYTOTOXICITY ISO 10993-10: IRRITATION.
Description:
EN ISO Medical Devices Laboratory needed for Biocompatibility testing - test should ensure that 5 materials are compliant with
EN ISO 10993-5:2009
ISO 10993-10:2010 and
EN ISO 10993-11:2009
Requirements:
Test should ensure that 5 materials are compliant with EN ISO 10993-5:2009 ISO 10993-10:2010 and EN ISO 10993-11:2009
Description:
USA ISO Medical Devices Laboratory needed for testing blood filter to ISO 1135-4.
Requirements:
testing blood filter to ISO 1135-4
Description:
France Europe ISO FDA GLP Medical Devices Laboratory needed for testing Infusion medical device to ensure Conformity to ISO10993
- Cytotoxicity (ISO 10993-5)
- Sensibilisation (ISO 10993-10)
- Irritation ou réaction intradermique (ISO 10993-10)
- Toxi...
Requirements:
FDA GLP ISO
Description:
India ISO Medical Devices Laboratory needed to test Latex free Tourniquet for biocompatibility as per ISO 13485.
Requirements:
ISO 13485
Description:
Belgique ISO Medical Devices Laboratory needed for ISO10993 testing:
-Determination of acute systemic toxicity -Determination of the acute dermal irritation -Determination of skin sensitization -Determination of the acite intracutaneous reactivity
Requirements:
ISO10993
Description:
USA Medical Devices/Mechanical Laboratory needed for ISO 22675 Testing to test prosthetic foot device to ISO 22675.
Requirements:
ISO 22675
Description:
India USP Medical Devices Laboratory needed for particulate testing as per 788.
Samples: PTCA Balloon Dilatation Catheter (02 samples)
Requirements:
USP 788
Description:
India ASTM Medical Devices Laboratory needed for Accelerated Testing for Sterile Class II Medical Device - Flexible porous packaging as per ASTM F1980.
Requirements:
ASTM F1980
Description:
India Medical Devices Laboratory needed for biocompatibility testing for stents
Description:
Europe Medical Devices Laboratory needed for in vitro diagnostic testing.
Description:
ASTM Medical Devices Laboratory needed for ASTM-F640-07 Radiopacity testing on medical catheter tubing according to ASTM F640-07: "Standard Test Method for Determining Radiopacity for Medical Use"
Requirements:
confidential please
Description:
Tennessee GLP Medical Devices Laboratory needed for biotesting on a disposable, polymer, sterile (eo), non-implantable device for a 510K submission to the FDA. This device will temporarily hold a blood sample, but a portion of that blood will be re-introd...
Description:
USA ANSI/AAMI Medical Devices Laboratory needed for testing as per ANSI/AAMI EC53 ECG Cable Defib testing ( 4.5.3 and 5.5.3 )
Number of samples = 4
Requirements:
ANSI/AAMI EC53 , paragraphs 4.5.3 and 5.5.3
Description:
Medical Device Laboratory needed for testing medical devices for Algeria Medical Device Manufacturer.
Description:
Saudi Arabia FDA Medical Devices Laboratory needed to test for Samples which are collected normally during inspection at the port of entry or at in establishment inspection or on healthcare facilities , or at local manufacture. Tests are required as f...
Description:
Florida ISO/CE Medical Devices Laboratory needed for testing as per EN60601-1
Requirements:
iso, ce
Description:
ISO Medical Devices Toxicology Laboratory needed for cytotoxicity testing of a medical device as per ISO-10993-5
Requirements:
ISO
Description:
Pacific Northwest/West Coast USA Medical Devices Testing Laboratory needed for testing Torque tightness of screw head to abutment of a dental implant system. Have a number of claims accepted patent pending to lock screw head to abutment.
Requirements:
Need engineers certification that proposed system does indeed lock screw head to abutment.
Description:
Analytical Chemistry, Medical Devices Laboratory needed for ASTM Accelerated aging Studies Testing in accordance to ASTM F1980 - 07.
Requirements:
ASTM, F1980 - 07
Description:
Medical Devices Supplier needs California FDA Laboratory for particulate testing on hydrophilic coating on a catheter.
Requirements:
fda requirement
Description:
Medical Doctor needs Medical Devices Laboratory for testing a pacemaker, output, rate, magnet function and sensing for FDA submission.
Requirements:
Report will go to FDA.
Description:
A2LA Medical Devices Laboratory needed to test in accordance to IEC 60601-1 second edition 1988 clause 44.7
Requirements:
Must have international accreditation such as A2LA
Description:
FDA Medical Devices Laboratory needed for compression measurement testing for compression type apparel such as calf and arm compression units using Hg measure.
Description:
ASTM Medical Devices Laboratory needed to test Radiopacity for Medical Lap Sponge as per ASTM F-640-7
Requirements:
ASTM F-640-7
Description:
Cleveland, OH (or close) ANSI Medical Devices Laboratory needed for testing of an ECG sensor array of 252 electrodes as per ANSI/AAMI EC12.
Requirements:
ANSI/AAMI EC12
Description:
FDA Laboratory needed for testing of indirect patient contact components in medical devices. Would like recommendations on testing components that contact the gas path and/or breathing system in an anesthesia machine. FDA currently considers gas path/bre...
Description:
India/Asia GLP Medical Devices Toxicology Laboratory needed for toxicology testing.
Requirements:
GLP
Description:
USA GLP ISO Medical Devices Toxicology Laboratory needed for Biocompatibility testing as per ISO 10993:
Cytotoxicity-
Sensitization(Maximization ISO) -
Irritation(Intracutaneous Reactivity)-
EO Residue Analysis
Limited use device (<24 hours) exposure...
Requirements:
GLP
Description:
INDIA MEDICAL DEVICES MATERIALS LABORATORY NEEDED IN-VITRO TISSUE STAPLERS TESTING ON ANIMAL TISSUES & STERILIZATION (AUTOCLAVE)
Requirements:
ABOVE TEST NEED TO BE DONE FOR 300 CYCLES
Description:
Medical Devices Manufacturer needs SGS Laboratory to conduct the following testing:
1- Packaging validation
2- Biocomptability test
(Sensitization Test& Irritation Test & Cytotoxicity Test).
3-Eto residual Test. TEST NAME Biocompatibility ISO 10993...
Description:
CHINA SFDA,FDA,GLP,USP,ASTM,ISO Preclinical Contract Research Organization needed to test the biocompatibility for medical devices such as stent or blood pooling bag.
Requirements:
SFDA,FDA,GLP,USP,ASTM,ISO 10993. also ISO/IEC17025
Description:
USA ISO Laboratory needed for fifteen samples of medical devices to be tested for phthalate in support of CE Mark.
Requirements:
ISO
Description:
USA/India FDA GMP/GLP Preclinical Contract Research Organization needed for in-vitro drug release analysis of medical device, Stability Studies for medical devices, Sample as required for testing.
Requirements:
FDA, GMP, GLP (Please make my contact information and company details Confidential )
Description:
Australia/USA GLP Laboratory needed for cytotoxicity testing of medical devices, contact lens. Agar overlay and direct contact. Must be GLP certified for regulatory body, TGA, CE mark
Requirements:
GLP
Description:
Pakistan ISO Bioanalytical Laboratory needed for bio-mechanical, bio-compatibility certificate in accordance to the article Regulation of Medical Devices as published by the General Directorate of the Ministry of Health.
Requirements:
ISO
Description:
Materials Laboratory needed for testing dozen different coatings we apply to medical devices. What we want tested is having the parts that are coated gamma sterilized. Our purpose is to determine if the different coatings react differently to gamma radiat...
Description:
Australia and Asia ISO 17025 Analytical Chemistry testing Laboratories needed for ETO residual testing in medical devices. Our laboratory is applying for ISO 17025 accreditation. We need to send samples to compare results.
Requirements:
ISO 17025
Description:
USA FDA GLP Physical Histology Laboratory needed for side by side comparison of cardiovascular devices testing against a predicate to substantiate equivalency claims for labeling.
Various models and analysis.
Requirements:
FDA, GLP
Description:
Microbiology Laboratory needed for ASTM Testing, ASTM F1714-96(2008) and Sterilization test for medical devices?
Description:
Canada Medical Device Microbiology Laboratory needed to validate manufacturer's reprocessing instructions for a medical device in accordance with Canadian Standard CSA-Z17664-06 "Sterilization of medical devices- Information to be provided by the manufact...
Requirements:
Canadian Standard CSA-Z17664-06
Description:
India Toxicology Laboratory needed for Biocompatibility testing of medical devices, cytotocicity, irritation, sensitization
Requirements:
1. CYTOTOXICITY2. IRRITATION3. SENSITIZATION
Description:
Analytical Chemistry Laboratory needed for ISO 10993 EO residual testing from medical devices
Requirements:
ISO 10993/7
Description:
USA FDA GLP Materials Laboratory needed for SEM analysis of explanted medical devices (surface analysis for degradation and infiltration)
Requirements:
FDA
Description:
USA FDA GMP Medical Devices Laboratory needed for Accelerated Aging Stability Studies.
Requirements:
FDA
Description:
Microbiology Laboratory required for medical sterilization test. We are in processing for a EC certification for class II b sterilization, so we need to provide a lab reference regarding to the sterilization result of our product.
our product details ca...
Requirements:
for EC and TGA certification, class II b sterilization for other medical devices.
Description:
Australia/Europe/Asia Preclinical Contract Research Organization needed for Medical Devices Biocompatibility Sensitization as per ISO 10993-10 and Cytotoxicity agar overlay method
Description:
FDA 510(k) Preclinical Contract Research Organization required for:
Medical Device Design and Modelling of Systems
Medical Device Compliance Testing
Reuseable Medical Devices Testing
Medical Devices Methods Development and Validation Testing
Medi...
Requirements:
FDA 510(k)
Description:
FDA 510(k, GLP, ISO, ASTM Bioanalytical and Microbiology Laboratory needed for the following:
Medical Device Sterility Testing
Medical Devices Microbiology Testing
Medical Device Microbial Identifications Testing
Medical Device USP Microbial Limits...
Requirements:
FDA 510(k, GLP, ISO, ASTM
Description:
FDA GLP, ISO, ASTM Preclinical Contract Research Organization needed for:
Medical Device Stability Studies Testing
Medical Devices Accelerated Aging Stability Studies.
Medical Devices Real Time Stability Studies.
Need estimates within 1 week for bu...
Requirements:
FDA 510(k), GLP, ISO, ASTM
Description:
FDA GMP Medical Packaging Laboratory required -
Need estimates for Budget in the within the next week.
Medical Devices Packaging Studies and Testing.
Medical Device Package Integrity Testing.
Medical Device Packaging Dye Penetration Testing.
Me...
Requirements:
FDA 510(k)
Description:
Analytical Chemistry/Toxicological Laboratory required for lab testing to validate a cleaning process. Will supply three unique medical devices at four levels of cleanliness (dirty, min, nominal and max clean). Number of samples needed open to agreement....
Requirements:
Confidential
Description:
USA medical devices company needs FDA GMP clinical research laboratory for in vitro performance testing of aerosol delivery device that includes cascade impactor particle size testing.
Requirements:
Test requirements must follow FDA CDRH document entitled:
Description:
ISO and FDA GMP medical devices laboratory needed for ASTM, MRI compatibility testing for class III medical implantable device (Active)
Requirements:
ASTM standards for passive implants, MRI environment to evaluate device functionality. Contact & Company to remain confidential
Description:
Medical Device Manufacturer requires US Laboratory for cytotoxicity testing on the medical devices we manufacture
Requirements:
FDA
Description:
Large Medical Devices Manufacturer needs USA microbiology laboratory for microbial testing of treated antimicrobial surfaces. Must be able to work with S. aureus and have access to a confocal microscope.
Requirements:
Please keep contact/company information confidential
Description:
USA Medical Devices Biomaterials Laboratory needed for evaluating new plasticizers to be used in our primary bags. We have narrowed the selection to DINCH (1,2-Cyclohexanedicarboxylic acid diisononyl ester) or TOTM (Tri Octyl Trimellitate). I would like t...
Description:
USA FDA GMP Analytical Chemistry laboratory needed for USP light obscuration particle counting test per USP <788> for medical devices
Description:
Asia Analytical Chemistry, Materials Laboratory needed for recertification testing of Polycarbonate Resin, old grade which are over 2 years (the guarantee shelf life is 2 years). These resin are to be done injection and built parts which are assembled on ...
Description:
Medical Devices Materials Laboratory needed for testing on HDPE and polypropylene for health certificate
Description:
Medical devices Manufacturere needs ASTM physical strength testing of interference screws and anchors according ASTM STD .
Requirements:
FOr interference scres and anchors: Fluence, la torque/torsion resistance and break angle due to torsión Anexo I ASTM F 543-07Insertion screw Anex A 2ASTM F 543-07Pull ouy strenght Anex A3 ASTM F 543-07Flexion essaysFor staples:Anex A 3 ASTM F 564-02anex...
Description:
US FDA Florida microbiology lab needed for bioburden testing of medical devices used to insert sutures.
Requirements:
FDA
Description:
ISO Asia microbiology and biomedical laboratory needed for all USP microbiological and physical testing on Medical Devices, Bone wax
Requirements:
USP,ISO
Description:
Large Medical Devices Manufacturer needs Bay, Area, California Non-CGMP Materials Lab needed for electron spin resonance of plastic extrusions. Looking to characterize free radical concentration at different times post irradiation.
Requirements:
non-cGMP but good record keeping a must
Description:
USA Packaging Lab needed to Provide temperature controlled environment, with humidity, for accelerated age testing of various sterilized and packaged medical devices. Lab to maintain large number of finished medical devices (potentially up to 8 pallets), ...
Requirements:
Confidential. No Testing may be required.
Description:
Large Medical Device Manufacturer needs Biomedical laboratory for ASTM D256 Testing of Medical Devices component
Requirements:
ASTM D256
Description:
Microbiology lab needed for microbial disinfectant efficacy study testing of microspheric beads used air-fluidized therapy (AFT) beds for patients with severe pressure ulcers (bed sores). The beads have to be disinfected after each patient use by heatin...
Description:
Biophysical laboratory capable of performing aging studies and tensile tests on woven collagen dressings needed. We are performing aging tests on samples of the dressings medical devices, and we wish to determine how long term elevated storage temperatu...
Requirements:
None.All contact info and company name is to remain confidential
Description:
Medical Devices Manufacturer needs materials laboratory for MALDI analysis of synthetic polymer
Requirements:
NA
Description:
Analytical Chemistry laboratory needed for medical devices -
501k Submission testing:
Cytotoxicity
Sensitization
Irritation
Ames Mutagencity
Product Sterility for final package (3 year expiry)
Gamma Irradiation Testing - radiation dos...
Requirements:
FDA 510K submission CONFIDENTIAL
Description:
Analytical Chemistry laboratory needed for sterility testing for EO Gas Sterilized Medical Devices
Requirements:
GMP or ISO
Description:
Medical Devices Laboratory needed for FDA (1 CFR 1611) Flammability Testing of Plastic
Requirements:
FDA (1 CFR 1611)
Description:
FDA GMP Microbiology laboratory needed for AAMI Testing of Cleaning and sterilization validation of medical devices reprocessed.
Requirements:
FDA, AAMI
Description:
ISO Medical Device Laboratory for cleaning efficacy validation and testing of reusable medical devices to AAMI TIR30, AAMI TIR12
Requirements:
EN ISO 17664:2004CONFIDENTIAL!
Description:
FDA GMP materials laboratory needed for GPC testing Medical Devices polymer MW weight
Requirements:
GMP
Description:
Microbiology laboratory needed for Cleaning efficacy validation and testing of reusable medical devices to AAMI TIR30. Manual and mechnical (washer-disinfector) cleaning validations on various reusable medical devices as per AAMI TIR30, ISO 15883 series, ...
Description:
ISO Medical devices laboratory needed for testing injectibles and IUDs
Requirements:
ISO stds
Description:
FDA Medical devices laboratory needed for testing infusion pump for regulatory submission and need verfication and validation testing to AAMI ID26:2004 and ISO60601-2-24.
Requirements:
FDA qualification
Description:
ISO, Non-GLP Medical Devices Materials Laboratory needed for ASTM Testing of a Polymer: melt flow (melt index), Molecular Weight (GPC), Rheology (Stress strain)
Requirements:
ISO, ASTM for Melt Index and Rheology. GLP is not required for GPC
Description:
Medical Devices manufacturer needs analytical chemistry laboratory for chemical testing process tank vapors.
Requirements:
Please keep this information confidential.
Description:
ISO Toxicology laboratory needed for Biocompatibility testing ISO 10993 -5 & 10.: Irritation, Cytotoxicity, Sensitasation, Irritation and Intracutenous reactivity test as per ISO 10993 -5 & 10 on Medical Devices.
Requirements:
ISO 10993 - 5 & 10
Description:
FDA GMP / GLP Medical devices laboratory needed for biocompatibility testing of medical devices
Requirements:
FDA; CEGMP and GLPpleae remain contact information confidential
Description:
GLP, ISO prouct safety laboratory needed for medical devices (biomaterial) biological safety testing including cytotoxicity
sensitization
irritation
genotoxicity
sub-chronic toxicity
implantation
Requirements:
GLP, ISO, confidential
Description:
FDA GMP medical devices laboratory needed for testing rapid test kit
Requirements:
FDA
Description:
ISO and FDA GMP medical devices laboratory needed for MRI compatibility testing for class III medical implantable device (non-active)
Requirements:
FDA / ISO
Description:
Medical Devices company needs ISO medical device laboratory for ISO 7206-6, Fatigue testing for hip prosthesis.
Description:
Medical Devices toxicology laboratory needed for ISO Cytotoxicity Testing (ISO 10993-5) for CE Marking and TUV Testing of upholstery materials
Requirements:
Ce Marking, TUV testing
Description:
GLP medical devices laboratory needed for processing fixed human coronary tissue from cassettes to H&E and Movat's pentachrome slides.
2) Using microscopy, classify pathology of coronary artery plaques according to a modified AHA scheme.
3) Using ...
Requirements:
GLP; please keep contact info and company confidential
Description:
Medical Devices manufacturer needs toxicology laboratory for ISO cytotoxicity testing (ISO 10993-5) for cytotoxicity of seat and back upholstery of wheelchair
Requirements:
ISO 10993-5
Description:
Toxicology laboratory needed for ANSI/AAMI/ISO 10993-6:1995, Biological Evaluation of Medical Devices-Part 6: Tests for Local Effects after Implantation. Tissue would arrive late April early May; Specimens from rats
Requirements:
Vetrinary pathologist; board certification
Description:
Medical Devices company needs analytical laboratory for determination of octanol water partition coefficient
Description:
FDA, ISO, AAMI Accelerated Durability/fatigue testing of implantable medical devices (principally stents) including DES
Requirements:
FDA, ISO, AAMI
Description:
GLP medical devices laboratory needed for mechanical, ASTM / ISO Fatigue testing on an implantable medical devices
Requirements:
Possibly GLP. If not, according to ASTM/ISO standard. Confidential.
Description:
GMP and GLP Laboratory needed for validation of the cleaning and thermal disinfection of medical devices, by microbiology methods ISO/DIS 15883-1 (or PR EN 15883-1) Washer Disinfectors., specifically using automated washer-disinfector equipment.
Requirements:
GMP and GLP required. Referencing ISO/DIS 15883-1 (or PR EN 15883-1) Washer Disinfectors.
Description:
Toxicology Polymer analysis for the compliance to the Biological evaluation of medical devices ISO 10993-10 Tests for irritation ISO 10993-5 Tests for in vitro cytotoxicity
Description:
particulates counts on guidewires medical devices
Requirements:
confidential
Description:
CT and MRI compatibility 10-20 Medical Devices samples; required are images of a device (>2cm length) using a 1.5-5T MRI and CT scanner.
Requirements:
Preferred method of contact: e-mail.
Description:
Provide temperature controlled environment, with humidity, for accelerated age testing of various sterilized and packaged medical devices.
Lab to maintain large number of finished medical devices (approx. 6000 (approx. 8 pallets), sterile, flat, tyvek/...
Description:
Water extraction, ISO 10993-17 in medical devices disposable set-fluid path for sterile, one time use only set
Description:
Testing of medical devices to GB/T14233.1-1998 & GB/T14233.2-1993
Requirements:
Would like to request for quote and turnaround time.
Description:
Bioburden testing on approximately 6 batches of medical devices a week. Batches consist of sample size of 10.
Requirements:
Bioburden testing per ISO11737-1. Contact and company name to remain confidential.
Description:
microbiological testing of water, OTC drugs, cosmetics and medical devices
Requirements:
confidential
Description:
USA FDA GMP Microbiology Lab needed for cleaning/ disinfectant efficacy testing for reusable medical devices. Class II. Surface (skin) temperature sensor.
Requirements:
FDA - cleaning method for reusable medical device (low level) - external on skin surface. Pleasse keep Confidential
