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.

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 ...

This presentation provides an overview of the Quality Management System Regulation, including preamble and final rule, a review of some important definitions and their hierarchy of application, and a ...

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 ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

The medical device industry has been anticipating harmonziation between FDA's quality regulation requirements and the international consensus standard for medical device quality for years. Now, it ...

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 attempt by the U.S. FDA to harmonize its Quality System Regulation (QSR) with ISO 13485 promises to be a difficult slog, but Jeff Shuren, director of the agency’s device center, said the agency is ...

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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 ...