Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

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.

Ambient Voice Technology (AVT) has seen a rise of popularity in clinical settings, mainly due to its potential to ease administrative burden by transcribing, and in some cases summarizing ...

One of the main challenges for medical device developers is ensuring clinical trials meet the expectations of all regulatory authorities in the regions where they wish to release. This will be a ...

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...

Device makers doing business in the EU finally have official word that the new implementation dates for the Medical Device Regulation (MDR) are in force, offering some vital breathing room for ...

DONGGUAN, GUANGDONG, CHINA, January 15, 2026 /EINPresswire.com/ -- As global healthcare regulations tighten and patient ...