Medical Device Testing is chief among our core services. Biofyl Scientific Research has extensive experience with both 510K and PMA application testing for CDRH or CBER review. We conduct independent comparative testing and substantial equivalence testing for FDA clearance/approval studies. A big percentage of medical device testing for FDA approved and developing autologous blood (CEBR) or bone marrow (CDRH) devices was done by BSR.
For Platelet-Rich Plasma and Bone Marrow concentrate production, BSR also offers protocol development and optimization services. We provide preliminary evaluations to establish baseline performance of devices for in-house quality control and assurance, as well as for marketing purposes. We also provide services for the optimization of centrifugation protocols in platelet and stem cell concentrate processing, using critical cell parameters as primary outcomes.
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In addition Biofyl Scientific Research also offers the following services: