Medical Device testing and FDA approval assistance
BSR offers services for Medical Device development and testing for FDA premarket submission or marketing studies. BSRhas experience with both 510K and PMA application testing for CDRH or CBER review. BSR provides independent comparative testing and substantial equivalence testing for marketing as well as FDA clearance/approval studies.
A large percentage of FDA approved and developing autologous blood (CEBR) or bone marrow (CDRH) devices were tested by BSR.
Click here for Medical Device testing and FDA approval assistance
