JD Supra

FDA Aligns Quality Systems Regulation With International Standards

The FDA issued a final rule which continues efforts to promote consistency in the regulation of devices and provides timelier introduction of safe and effective high-quality devices for patients.
JD Supra

FDA Issues Long-Awaited Quality System Regulation Amendments

After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. In a ...
MD&M East

Medtech Implementation of FDA’s Updated QMSR

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 ...
American Enterprise Institute

Congress Must Update FDA Regulations for Medical AI

The FDA’s firm-based approach to regulating medical devices means that the regulatory oversight focuses on the quality systems and processes of the manufacturing firm, rather than just on the ...
The National Law Review

FDA Finalizes Revised Medical Device Quality System Requirements, Issues Remote Regulatory Assessments Guidance

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 ...
Becker's ASC

Polymicro Technologies Achieves FDA Quality System Regulation Registration, Compliance

Polymicro Technologies, a subsidiary of Molex, announced its registration and compliance with the U.S. Food and Drug Administration 21 CFR 820 Quality System Regulation. The Polymicro Technologies ...
Newsweek

Navigating FDA Regulations: A Comprehensive Overview for MedTech Leaders

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.
BioWorld

FDA renews plan to align quality management rules with ISO standard

The FDA’s multiyear effort to rewrite the Quality System Regulation (QSR) to align with ISO 13485 could significantly ease the regulatory burden for device makers in multiple markets, but that effort ...
MD&M East

How Will FDA’s New QMSR Affect Medical Device Companies?

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 ...
BioWorld

US FDA sees new QMSR as part of push toward culture of quality

The U.S. FDA’s device center has been prodding industry for some time to develop a culture of quality regarding the manufacture of medical devices, an emphasis that has resulted in the development of ...
The National Law Review

Quality System Harmonization Is Here, But with Small Benefit to Device Industry

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 ...