Category: FDA QMSR

Training Under the QMSR Framework The Quality Management System Regulation, through its incorporation of ISO 13485:2016, establishes clear requirements for personnel competence, training, and awareness. Clause 6.2 of ISO 13485 requires organizations to determine the necessary competence for personnel performing work affecting product quality, provide training or take other actions to achieve the necessary competence, evaluate the effectiveness of…

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The Stakes of FDA Inspection An FDA inspection can be one of the most consequential events for a medical device manufacturer. The outcome can range from a clean inspection with no observations to Form 483 observations, warning letters, consent decrees, injunctions, or even criminal prosecution. The difference between these outcomes often lies in the organization’s preparation — specifically, how…

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Documentation Under the QMSR: A New Framework The Quality Management System Regulation (QMSR) has fundamentally changed how medical device manufacturers must think about quality system documentation. By incorporating ISO 13485:2016 by reference, the QMSR aligns U.S. documentation requirements with international expectations while retaining certain FDA-specific provisions that reflect the unique demands of the American regulatory environment. Documentation is the…

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Risk Management Under the QMSR Framework Risk management has always been a fundamental expectation for medical device manufacturers, but the transition to the Quality Management System Regulation (QMSR) elevates its importance and demands a more systematic, integrated approach. Under the QMSR, risk management is not a standalone activity — it is a thread that must run through every element…

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Complaint Handling Under the QMSR: What Has Changed The transition from the legacy Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) has brought significant changes to how medical device manufacturers must manage customer complaints and feedback. Under the QMSR, complaint handling is governed by a combination of ISO 13485:2016 requirements and FDA-specific additions that together create…

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Understanding Design Controls Under the QMSR Design controls have always been a cornerstone of FDA medical device regulation, and the transition from the legacy Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) has introduced meaningful changes to how manufacturers must approach design and development activities. Under the QMSR, design controls are now anchored in ISO 13485:2016…

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Navigating QMSR compliance requires a systematic approach. This comprehensive checklist covers the essential steps medical device manufacturers should take to ensure their quality management systems meet the requirements of the FDA’s Quality Management System Regulation. Documentation and Structure Review and update your quality manual to align with ISO 13485 structure and QMSR terminology. Ensure your QMS scope is clearly…

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The QMSR introduces updated expectations for how medical device manufacturers manage their supply chains. With supplier audit records now subject to FDA inspection, organizations must ensure their supplier management programs are robust, well-documented, and defensible. Supplier Controls Under QMSR The QMSR’s supplier control requirements are derived from ISO 13485:2016 Clause 7.4, which addresses purchasing processes, purchasing information, and verification…

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The QMSR has changed the landscape for internal audits at medical device companies. Not only must internal audit programs now align with ISO 13485 requirements, but the fact that internal audit records are now subject to FDA inspection adds a new dimension to how these programs should be managed. Internal Audit Requirements Under QMSR Under the QMSR, internal audit…

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Understanding the history of FDA quality system regulation provides important context for the current QMSR framework. The evolution from the original Good Manufacturing Practice (GMP) regulations through the Quality System Regulation to today’s QMSR reflects decades of regulatory learning and industry growth. The Early Days: GMP Regulations The FDA’s regulation of medical device manufacturing began with the Medical Device…

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