EU is moving from MDD to MDR. Are you ready?

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…

Dealing with Soft Requirements

In the ideal product development project the client would provide a thorough and well-written set of requirements that can be unambiguously understood and implemented by the engineering team. Of course, this almost never happens in practice. Sometimes the requirements we’re given are so “soft” that they aren’t even really quantifiable. That kind of requirement can be extremely difficult to design to during a product development effort. So what can you do?