Proposals include establishing "indirect recognition" of EU CE-marked devices to the UK market and "international reliance" ...

The implications of medical device regulations on market entry strategies are profound. Credit: Doidam 10/Shutterstock.com. The medical devices industry is always undergoing significant regulatory ...

Artificial intelligence (AI) in health care is rapidly advancing beyond traditional applications. Autonomous AI agents are ...

The digital health medical device industry simply cannot thrive within the traditional regulatory structure, a challenge that has previously been addressed by Congress in 2016. The 21st Century ...

Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing ...

State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own ...

Designing medical devices for such varied use cases requires more than just technical proficiency. It calls for strategic ...

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 deal eliminates tariff barriers and aims to ease regulatory processes, creating room for Indian companies to expand in ...

Dublin, June 30, 2025 (GLOBE NEWSWIRE) -- The "Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course" training has been added to ResearchAndMarkets.com's ...

Former U.S. President Donald Trump signed proclamations that provide a two-year reprieve from certain Biden-era EPA ...