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

This request is closed and is no longer accepting quotes. Register or Log In to receive alerts when similar requests open in the future.
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,

Test Request: 25-00910

Looking for ASTM F64-23 testing for radiopacity of inferior vena cava (IVC) medical tubes.


view


Test Request: 25-00820

We would like to receive a quote and lead time on performing a dielectric strength test on an epoxy resin in two differe... view


Test Request: 25-00759

MULTIPLE SAMPLES
(English follows)
Precisa de um laboratório no Brasil para testes de cama... view