ISO 13485 is the cornerstone standard for quality management in the medical device industry. Whether you are pursuing certification, maintaining compliance, or preparing for a customer or regulatory audit, understanding what an ISO 13485 audit entails is essential for every medical device organization. Understanding ISO 13485 Audits An ISO 13485 audit is a systematic examination of your quality management…
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…
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…
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…
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…
The transition from the Quality System Regulation (QSR) under 21 CFR Part 820 to the Quality Management System Regulation (QMSR) represents a fundamental shift in how the FDA regulates medical device quality systems. Understanding the key differences between these two frameworks is essential for manufacturers navigating the transition. Structural Differences The most fundamental difference between the QSR and QMSR…
The FDA’s transition to the Quality Management System Regulation (QMSR) has fundamentally changed how medical device manufacturers are inspected. Understanding what to expect during an FDA inspection under the QMSR framework is essential for preparation and success. The New Inspection Approach With the QMSR in effect, the FDA retired the Quality System Inspection Technique (QSIT) that had been used…
A QMSR gap analysis is one of the most important steps medical device manufacturers can take to ensure compliance with the FDA’s Quality Management System Regulation. By systematically comparing your current quality system against QMSR requirements, you can identify deficiencies before they become regulatory findings during an FDA inspection. Understanding the QMSR Gap Analysis A gap analysis is a…
With the FDA QMSR now in effect, conducting a thorough readiness assessment is critical for medical device manufacturers who want to ensure their quality systems meet the new regulatory requirements. A QMSR readiness assessment goes beyond a simple documentation review — it evaluates whether your organization’s quality management system is fully aligned with the combined requirements of ISO 13485:2016…
The FDA’s Quality Management System Regulation became effective on February 2, 2026, marking the end of a two-year transition period and the beginning of a new era in medical device quality regulation. Understanding the timeline, current requirements, and what to expect going forward is essential for every medical device manufacturer. The QMSR Timeline The journey to QMSR began years…
Qualyx Group provides independent, audit-only services for organizations operating in highly regulated environments, including medical devices, diagnostics, and aerospace. Our audits are conducted with OEM-grade rigor, objectivity, and a risk-based focus — without consulting, implementation, or conflicts of interest.
We work with organizations operating in highly regulated environments to provide independent, audit-only services. A free initial consultation is available.
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