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

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 ...

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

China latest policy measures for high-end medical devices signal a major push to accelerate industry innovation and global ...

Review Of US Medical Device Regulation Published Date: January 10, 2008 Source: InHealth: Institute for Health Technology Studies Summary: A review of the background, mission and statutory ...

Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from ...

The Global Medical Device Regulatory Affairs Market size is projected to grow from USD 8.13 Billion in 2022 to USD 11.75 Billion by 2030, at a Compound Annual Growth Rate (CAGR) of 8.91% during ...

The new EU Medical Device Regulation (MDR) (2017/745) will enter into application on 26 May 2020. It was published on 5 May 2017, following a years-long revision process.

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.