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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 ...

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 ...

The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.

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. 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 agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System regulation violations by Olympus.” The FDA sent three warning letters to ...

The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...

One of the most controversial topics in the diagnostics space is FDA’s proposed regulation to oversee laboratory-developed tests (LDT). Most recently, FDA and the Centers for Medicare and Medicaid ...