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 ...

The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 ...

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.

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 ...

Prefer Newsweek on Google to see more of our trusted coverage when you search. In the changing field of technology, progress is driven by the pursuit of innovation which plays a vital role in ...

The Department of Health and Human Services (HHS) on Wednesday released the spring version of its unified agenda on proposed and final rulemakings, featuring a proposed rule on quality system ...

A US Food and Drug Administration (FDA) spokeswoman told Focus on Wednesday that as part of global harmonization efforts around quality management systems, the agency is considering adding clauses ...

With technological advancements in the medical device industry come heightened regulatory expectations, and rightly so. Of late, regulatory expectations for medical devices are shifting faster than ...

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...