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

Düsseldorf District Court issues preliminary injunction against Beijing Hanbaihan Medical Devices Co., Ltd. regarding ...

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

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 ...

The European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance deadlines are just around the corner. However, with the transition or ‘standstill’ period ...

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 ...

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 ...

The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic. According to the European Commission, the Medical Devices ...

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 ...