5 Things You Should Do to Prepare for the New European Union Medical Device Regulation (EU MDR)
Medical devices cannot be placed on the market without conforming to safety requirements. In the U.S., the responsible regulatory agency for medical devices is the FDA’s Center for Devices and Radiological Health (CDRH). If it is a drug and device combination product, it is the CDER, Center for Drug Evaluation and Research, as well. The…
