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 ...

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

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

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

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 ...

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

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 ...

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.

These regulations are focused more on traditional medical devices, so software classifications may be more difficult to determine. SaMD products may also contain software of unknown pedigree or ...

Under the EU's Medical Devices Regulation (MDR), which came into effect in May 2021, all medical devices, from implants and prosthetics to blood glucose meters and catheters, must meet stricter ...

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

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 ...