After proposing to align its medical device Quality System Regulation (QSR) with the international standard ISO 13485:2016, the US Food and Drug Administration (FDA) has offered a look at its chief ...

We spend a lot of time with manufacturing leaders, quality teams, and in-house counsel who are all talking about the same basic issue, just ...

The US Food and Drug Administration (FDA) issued draft guidance for device makers that outlines its expectations for implementing the Quality Management System Regulation (QMSR). The guidance details ...

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...

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 ...

AI labs advance: Ginkgo Bioworks’ autonomous labs now integrate 70 robots and AI systems capable of designing and running complex experiments with minimal human intervention. Regulatory shift: The FDA ...

The U.S. FDA’s attempts to harmonize with other nations on quality management received a dose of good news recently when the International Organization for Standards decided to stand pat on ISO 13485, ...

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 ...

Expert insights on QMSR compliance: transition steps, gap assessments, risk-based approach, and global harmonization with ISO 13485 standards.