Medical Devices includes a session from a regulatory expert on how companies can align their research between regions.

The European Union's Medical Device Regulation (EU MDR) has become much more sophisticated and specific. Since taking effect in May 2017 the EU MDR includes more challenging protocols, including new ...

MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...

Completing a process started about 13 years ago, new rules for how medical devices are evaluated and brought to market in the European Union (EU) came into full force last Wednesday—with implications ...

These technologies are improving all the time. If they’re not making claims that they are medical grade, let’s let the market ...

A recent study led by researchers at the Yale School of Medicine and Harvard Medical School found that a loophole in existing regulation has allowed manufacturers to acquire U.S. Food and Drug ...

GENEVA--(BUSINESS WIRE)--Medimaps Group, a Swiss/Global med-tech company specializing in image-processing software with AI capabilities for assessing bone health, announced today it received the ...

On April 11, AEI’s Brian J. Miller hosted Jesse Ehrenfeld of the American Medical Association and Jeff Shuren of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health to ...