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 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 ...
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 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.
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 ...
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 ...
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