Laboratory Test Request

FDA GLP and ISO Oxygenator Model Performance, Safety, and Biocompatibility Testing

Project Description

MULTIPLE TESTING
FDA GLP Medical Device Laboratory needed for ISO performance, safety, and biocompatibility testing of a new oxygenator model designed for use with CPB Cardiopulmonary bypass machine. Testing will be performed on 3 different animal models to make sure it exceeds the following relevant clinical and regulatory standards:
- ISO 14708 for implantable medical devices and ISO 10993 for biocompatibility testing
- Institutional Animal Care and Use Committee (IACUC)
- Animal Welfare Act
- Good Laboratory Practice (GLP)

Project Information

Number:23-02889

Industry:Medical Devices

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Healthcare and Medical,Hospitals and Medical Centers,Life Sciences,Medical Devices,Medical Devices (Electrical),Medical Devices (Reusable),Medical Devices - Sterile,Medical Equipment,Medical Research,Medical Technology,

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