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 ...

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

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

The U.S. Department of Justice (DOJ) has officially closed its nearly two year investigation into Kraken co founder Jesse ...

Laboratory carried out a survey to find out how the profession feels about the question of illegal manufacture – here are the ...

With Internet of Things (IoT) devices in nearly every home, regulators worldwide are stepping up to enforce meaningful ...

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

Federal Minister for National Health Services Syed Mustafa Kamal chaired a high-level meeting of the Drug Regulatory ...

The Electronic Health Record Association wants Health and Human Services leaders to address conflicting rules for analytics tools, and also seeks clarity on electronic case reporting requirements.

The Government is set to amend UK medical devices regulations by adopting EU Common Specifications for high-risk in vitro ...