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Most Recent validation and qualification Laboratory Requests

Contract Laboratory has received the following validation and qualification Laboratory Requests which need to be fulfilled! These validation and qualification Laboratory 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 Labs to perform their validation and qualification Laboratory and Scientific Research. If you need a validation and qualification Laboratory, please Submit a validation and qualification Laboratory Request. If you need assistance or have questions contact us online or call toll free 1-855-377-6821. Please log in to see more.

Test Requests Service Requests Product Requests Business Request

Title:

Pharmaceutical / Medical Device DSC Analysis

Description:

FDA cGMP Laboratory needed for Differential scanning calorimetry DSC analysis of 30 samples of a combination pharmaceutical/medical device according to our methods.

Requirements:

Please provide ballpark cost including set-up fee.

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Title:

AAMI ECG Electrode

Description:

Medical Device Laboratory needed for AAMI testing of disposable ECG electrodes to standard - AAMI EC12:2000/R2015. The tests required are, DC offset, AC impedance, Noise, Bias and Defibrillation overload recovery.

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Title:

Soft Contact Lens Testing

Description:

Medical Device Laboratory needed for soft contact lens testing for measurements such as: light transmittance, mechanical properties, oxygen permeability.etc.

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Title:

FDA Toothbrush Verification Testing

Description:

FDA laboratory needed for confirmatory and verification testing of imported toothbrushes. Toothbrushes are received with a testing report and need testing to verify.

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Title:

Medical Device Cytotoxicity and In Vitro Irritation

Description:

Medical Device Laboratory needed for ISO testing of medical disposables to ISO 10993-5 Cytotoxicity and ISO 10993-10 Irritation Oral Stimulation and Bipolar Irritation Test (in vitro)

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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

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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

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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.

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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...

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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

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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.

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Title:

Implantable Medical Device Simulation

Description:

Medical Device Laboratory which has a MRI scanner needed for evaluation of implantable medical device.

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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

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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...

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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...

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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

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Title:

Drug Product Compatibility Testing

Description:

Pharmaceutical company needs Laboratory to perform ASTM condom compatibility testing of a drug product according to ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

Requirements:

ASTM D72661-10 Standard Test

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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.

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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.

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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

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Title:

Air Purifier Evaluation

Description:

PRODUCT DEVELOPMENT Microbiology Laboratory needed for particulate and virus/bacteria count from an air purifier to be manufactured

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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...

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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.

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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

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Title:

Optical Testing

Description:

Large Innovative Electronics Company needs Materials Laboratory for wavefront optical testing.

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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.

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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.

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Title:

Toxicity of Menstrual Device

Description:

Medical Device Toxicology Laboratory needed for toxicity study testing for menstrual device.

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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

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Description:

Medical Device Laboratory needed for ISO mechanical testing for joint simulator tests to ISO Standards ISO 14243, ISO 14242, ISO 18192


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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.

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Description:

Medical Device Laboratory needed for shelf life testing of clinical medical devices

Requirements:

Please provide quote

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Description:

Medical Device Company needs FDA Laboratory for Washer/Disinfector Cleaning validations

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Description:

Medical Device Company needs 3rd party Product Safety Laboratory for Biocompatiability testing (cyto, irritation, sensitization)

Requirements:

ISO standards

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Description:

Medical Device Company needs Laboratory for cleaning validation testing to ISO standards.

Requirements:

ISO standards

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Description:

Medical Device Laboratory needed for AAMI testing of for surgical gown to EN 868 part 2 for sterilization bag reel pouch

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Description:

FDA GLP Product Safety Laboratory needed for biocompatibility testing for medical devices

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Description:

Large Medical Device Company needs Laboratory for transportation environmental simulation studies on sterile disposables to simulate distribution across the globe

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Description:

Analytical Chemistry Laboratory needed for testing to detect low concentration of Sodium Hypochlorite (0.04% -0.06%) in Hydrogel topical cream .

Requirements:

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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...

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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.

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Description:

USA Healthcare Manufacturer needs Microbiology Laboratory for bacterial analysis of r paraffin baths.

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Description:

Microbiology Laboratory needed for virus penetration testing on latex condoms.

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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.

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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.

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Description:

Medical Device Laboratory needed for specification testing of #30 Dental Cements

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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...

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Description:

FDA GMP Dermatology Clinical Research Laboratory needed for clinical study with skin prick testing of a new protein based wound dressing on 20 patients.

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Description:

Bioanalytical Laboratory needed for Bovine Collagen III detection in Bovine Collagen I samples per ASTM impurity profile

Requirements:

ASTM

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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.

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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

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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

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Description:

Medical Device Laboratory needed for sterilization procedure verification for an invasive tool with Autoclave Class B - ALARA type.

Requirements:

Please provide quote.

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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:



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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...

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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.

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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.

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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

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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.

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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

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Description:

Medical Device Manufacturer needs biomechanical laboratory for ISO 10328 Lower limb prosthesis structural testing

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Description:

Large Medical Device Manufacturer needs Third-Party Laboratory for performance testing of a room air cleaner for smoke and pollen.

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Description:

Medical Device Manufacturer needs materials laboratory for grout analysis for reformulation purpose

Requirements:

IMPORTANT NOTE: Please provide quotation.

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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 ...

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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?

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Description:

Medical Device Laboratory needed for sterilization validation testing of surgical instruments.

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Description:

Medical Device manufacturer needs Contract Sterilizer for gamma or e-beam sterilization of diamond dental burs

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Description:

LONG-TERM SERVICES Medical device company needs contract sterilizer for gamma sterilization and packaging of plastic disposable petri dishes.

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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

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Description:

Medical device company needs FDA consultant for advising on the registration and classification of self diagnostic kits prior to manufacturing.

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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.

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Description:

LONG-TERM Contract Sterilizer needed for gamma sterilization of medical devices starting at 300,000 units going to 1 million in a year

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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

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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

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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.

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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

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Description:

MEDICAL DEVICE LABORATORY NEEDED FOR ISO TESTING OF RESUSCITATOR AS PER ISO 10651-4. LUNG VENTILATORS

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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

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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

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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.

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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)

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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.

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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,

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Description:

FDA compliant laboratory needed for a one-cycle Steam Sterilization Validation Study for a medical device

Requirements:

FDA Compliant
One cycle
Gravity Displacement

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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

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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:

-

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Description:

LONG-TERM TESTING Medical Device Laboratory needed for dynamic fatigue testing of endosseous dental implants to ISO 14801

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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).

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Description:

Clinical laboratory needed to perform clinical study of product that lowers your blood alcohol content with 150 people with 100 being given the product and 50 a placebo. The test subjects will have to drink three 1.5 ounces of vodka in an hour. Their bloo...

Requirements:

We will have to do a hangover study follow up the next day with the 100 people who took the product to prove that they had no hangover.

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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...

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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.

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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.

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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...

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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.

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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

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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...

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Description:

Medical device microbiology laboratory needed for sterility testing of various medical device sets.

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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

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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...

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Description:

Medical Device company needs packaging laboratory for transportation simulation studies of polypropylene and polyethylene medical devices with a shelf life of 5 years.

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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.

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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

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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.

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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.

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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

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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.

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Description:

Medical device laboratory needed for biocompatibility testing of long term orthopedic implants to ISO 10993-1 (Biological Evaluation of Medical Devices)

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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...

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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.

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Description:

Orthopedics medical device laboratory needed for physical certification testing of prosthetic devices to ISO10328 (Prosthetics - Structural) for a lower limb prosthesis

Requirements:

ISO10328

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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...

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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

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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...

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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.

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Description:

FDA cGMP medical device laboratory needed for condom biocompatibility testing in accordance to FDA guidelines.

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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...

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Description:

Laboratory needed for waterproof testing of medical alert device to International Electrotechnical Commission (IEC) IP code rating IPX6.

Requirements:

Not sure

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Description:

Medical device / materials laboratory needed for ASTM testing of personal protective equipment / gloves to ASTMF2878-10 (Needle Stick Test)

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Description:

Consumer Products Safety Laboratory needed for FDA sunglasses safety testing by drop ball test method to Standard LT-1 July 12, 1971 21 CFR 801, 410 MIL-STD-105.

Requirements:

Sunglasses Association of America Standard LT-1 July 12, 1971
21 CFR 801, 410
MIL-STD-105

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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.

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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.

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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.

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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...

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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...

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Description:

Medical Device company needs physical chemistry laboratory for surface tension and surface energy testing

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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

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Description:

Oncology Preclinical Contract Research Organizations CRO needed for in vivo studies of primary or metastatic hepatic / liver cancer using VX2 rabbit and/or Walker 256 rat/mouse orthotopic models. CRO must allow drug payload to be delivered by an external...

Requirements:

Confidential

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Description:

Molecular diagnostic company needs Contract Research Organization CRO for biocompatibility and toxicity studies

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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

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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.

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Description:

Medical device safety laboratory needed for biocompatibility testing of medical devices.

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Description:

FDA GMP laboratory needed for USP testing of length and length distribution of purified cotton fiber to USP <691> for large international healthcare company.

Requirements:

GMP laboratory required with appropriate documentation

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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).

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Description:

Molecular Diagnostics company needs Contract Research Organization CRO for biocompatibility testing services.

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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.

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Description:

Health company needs materials laboratory needed for non-destructive NDT optical testing including surface roughness analysis of non-flat surface.

Requirements:

Non-destructive, preferably optical.

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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

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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...

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Description:

Medical Device Laboratory needed for Acoustics and Bench Testing:  Sound Velocity, Acoustic Impedence, Sound Attenuation; Physical Measurements:  Viscosity, and Density of ultrasound gel

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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.

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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...

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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.

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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

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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...

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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

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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.

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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

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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).

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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.

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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.

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Description:

Medical Device company needs materials laboratory for mirror testing for reflectivity in the spectra range 600 nm - 1100 nm.

Requirements:

India preferred.

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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

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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

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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

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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

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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

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Description:

Medical device laboratory needed for permeability testing of different fabrics for patient comfort.

Requirements:

Permeability
Breath-ability

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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...

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Description:

Radiochemistry laboratory needed for medical imaging certification testing of X-ray imaging machine.

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Description:

Medical device laboratory needed for validation testing of endoscopy instruments.

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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.

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Description:

Analytical laboratory needed for testing medical devices.

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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

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Description:

FDA Consumer Products Safety Laboratory needed for sunglasses testing to meet FDA regulations for importation.

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Description:

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...

Requirements:

The IEST RP-CC005.4 test is our primary goal. We can have the gloves tested for items 1-4 elsewhere if you do not have the ability to perform these procedures. If you can, we would prefer utilizing one test facility.

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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...

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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

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Description:

Personalcare company needs medical device laboratory for Health Canada Class ii tampon compliance testing prior to importation into Canada.

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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.

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Description:

Medical device company needs Electromyogram (EMG) done for small muscle activity related to eye movements.

Requirements:

Sensitive EMG equipment for small muscle activity

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Description:

USA Laboratory needed for Modulated Differential Scanning Calorimetry (MDSC) mDSC testing from -80C to 80C

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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

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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

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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

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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

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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

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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.

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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.

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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...

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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.

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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.

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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

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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

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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

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Description:

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 ana...

Requirements:

Some work has already been invested in developing an dual analyte LC-MS-MS method, and are interested in established labs with this testing capability. Ability to work with dried samples of no more than 40 mg per test is desired. Previous successful work...

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Description:

Non-GLP research laboratory needed for Optimization of real time PCR for diagnostics

Requirements:

without GLP

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Description:

FDA registered Medical device laboratory needed for Residual solvent testing in Transdermal Patch

Requirements:

FDA registered

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Description:

Genetics Laboratory needed for DNA and RNASE removal (cleaning) testing for disinfectants to remove DNA and RNASE

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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

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Description:

Medical Device Laboratory needed for toothbrush bristle testing for stiffness of toothbrush bristle

Requirements:

testing to be done by instrument TRIBOMETER

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Description:

Medical Device Laboratory needed for quality control testing of sanitary pads for all quality parameters including physical measurements.

Requirements:

as said above

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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.

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Description:

Preclinical Bioanalytical laboratory needed for biological medical device testing: FGF2 and glycosaminoglycans content in small intestine submucosa medical device

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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

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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.

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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...

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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...

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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.

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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 ...

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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...

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Description:

Biomechanical laboratory needed for bone porosity testing measurements of bone samples

Requirements:

Any method used for bone porosity testing

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Description:

Acoustics laboratory needed for ultrasound gel testing: sound velocity, acoustic impedance, sound attenuation. Please provide price quote.

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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).

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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:


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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

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Description:

Medical device company needs virology laboratory for virus testing of surgical products Biologics

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Description:

LONG-TERM TESTING Large Medical Device Company needs materials laboratory for RAL-GZ 387/1 compression testing for fabric

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Description:

Medical Device Laboratory needed for testing to develop methods for airway obstruction / choking hazard analysis

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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

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Description:

Orthopedics company needs medical device product safety laboratory for accelerated ageing testing of Orthopaedic implants in tyvek pouches including extracables and leachable testing

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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.

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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...

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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...

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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

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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...

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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.

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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%.

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Description:

FDA Acoustics laboratory needed for testing new ultrasound gel that will be to FDA requirements. these testing are 1. sound impedance testing 2. sound transmittance testing 3. acoustics testing

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Description:

Medical device laboratory needed for chemical characterization testing of nylon surgical sutures for ISO1993 compliance.

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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...

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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.

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Description:

Technology company needs FDA certified laboratory for Product deformulation required of popular beverage in powder format.

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Description:

Physical Laboratory needed stress testing done on chiropractic table equipment

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Description:

CAP or CLIA certified histology laboratory needed to process and analyze paraffin blocks of human skin samples that we would like to have cut for slides, and then subsequently analyzed for H&E and Gomori?s Trichrome.

Requirements:

CAP or CLIA certification

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Description:

Medical technology laboratory needed for catheter testing on intravenous catheter throughout the indicated therapy to check on thrombosis and flow rate.

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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...

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Description:

Medical Technology / Biomedical laboratory needed for catheter testing: Embolic cube testing

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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:

¬

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Description:

Medical Device laboratory for identification testing for the detection of cutting oil (mobilmet 766) on dental implants

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Description:

Medical Device Laboratory needed for transdermal patch testing of adhesive ingredients for milligrams of 5-HTP and Magnesium Oxide are contained within the patch.

Requirements:

As described above.

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Description:

USA Analytical Chemistry Laboratory needed to do some validation and qualification testing on reagents that are received from outside vendors to confirm that the certificate of analysis that we receive from the manufacturer is accurate. The following reag...

Requirements:

Yes, keep confidential.

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