Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...

In the changing field of technology, progress is driven by the pursuit of innovation which plays a vital role in enhancing patient care, prolonging lives, and improving overall healthcare outcomes.

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

The U.S. Food and Drug Administration published a draft guidance this past week with regard to medical device cybersecurity. The draft guidance, "Cybersecurity in Medical Devices: Quality System ...

On Feb. 2, 2024, FDA published its long-awaited amendment to its current good manufacturing practice requirements for medical devices. The new Quality Management System Regulation (QMSR) now ...

The draft guidance issued Thursday, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, covers a wide range of cybersecurity device design, labeling ...

With over 50 years of direct experience with the FDA, RQM+ provides regulatory affairs and quality assurance solutions for MedTech that assist innovators in achieving and sustaining global compliance.

The Food and Drug Administration issued a warning letter to Philips citing significant violations at three of its medical device facilities. The inspections took place between January and March 2025 ...

The draft is a near total overhaul of the document finalized by FDA in 2005, with only short sections on topics such as software verification and the history of software revisions surviving unchanged.

Glucotrack, Inc., a medical technology company specializing in diabetes solutions, announced it has achieved ISO 13485:2016 certification from the British Standards Institute, marking a significant ...