Etienne Nichols, a medical device guru and community manager at Greenlight Guru, recently posed an interesting question to his LinkedIn network: If you were in charge, what regulation would you change ...

DMHTs sit within a broader wave of digital health technologies, helping manage a range of issues such as asthma with smart ...

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 ...

January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...

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 ...

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 ...

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 ...

In recent years, there has been an uptick in interest in the Chinese market from licensors based predominantly in the U.S., Canada, Europe, and South Korea. Factors encouraging the in-licensing of ...

Arena International's Outsourcing in Clinical Trials: Medical Devices includes a session from a regulatory expert on how ...