U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low ...

Dublin, March 25, 2025 (GLOBE NEWSWIRE) -- The "Global Handbook of Medical Devices Regulatory Affairs 2025" directory has been added to ResearchAndMarkets.com's offering. Medical device regulation ...

The 2024 study, of 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), started by reviewing medical device suppliers ...

Regulatory shifts may lead to temporary device shortages in the short term. Medical device companies are anticipated to ...

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...

Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments ...

Dr. Chandar Thakur, chief of the Medical Devices and Diagnostics Branch at DHA R&D-MRDC’s Office of Regulated Activities, is the 2024 Employee of the Year.

Artificial intelligence offers a wide range of opportunities to make medical devices more efficient. How the AI Act and ...

Some of the India medical devices companies have started work on regulatory filings and paperwork, to ensure they do not miss ...

The Indian medical device industry faces challenges from international trade dynamics, regulatory barriers, and domestic ...

A steep 27% US tariff threatens India’s medical device exports, but regulatory hurdles may pose an even bigger challenge. Can ...