The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

Market Surveillance - Practical Application for Medical Devices and IVDs Training Course (ONLINE EVENT: February 12, 2025)" has been added to ResearchAndMarkets.com's offering. Understanding the ...

The MHRA has issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes.

ChBE alumna Brittany Michael sent the following job announcement. My direct client, one of Boston's top medical device companies in Boston, MA is hiring a Post-market Surveillance Engineer for their ...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" training has been added to ResearchAndMarkets.com's offering.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical ...

A suite of guidance has been published by the UK Medicines and Healthcare products Regulatory Agency (MHRA). This guidance is designed to help medical device manufacturers understand and prepare for ...

and quality of medical devices throughout their lifecycle, from design and development to post-market surveillance. This article outlines a robust framework for such a regulatory model ...