With the FDA QMSR now in effect as of February 2, 2026, medical device manufacturers face a new regulatory reality. Compliance is no longer optional, and the FDA has already begun conducting inspections under the new framework. Here is what you need to know to ensure your organization is prepared. The Compliance Deadline Has Passed Unlike some regulatory transitions…
The FDA Quality Management System Regulation (QMSR) represents the most significant change to medical device quality system requirements in the United States in decades. Effective February 2, 2026, the QMSR replaces the legacy Quality System Regulation (QSR) under 21 CFR Part 820 by incorporating ISO 13485:2016 by reference. What Is the QMSR? The QMSR is the FDA’s effort to…
Supplier quality is one of the most critical — and often underestimated — factors in maintaining product quality and regulatory compliance. For organizations in medical devices, diagnostics, and aerospace, the performance of your supply chain directly impacts patient safety, product reliability, and regulatory standing. Why Supplier Audits Are Essential Regulatory frameworks such as ISO 13485 and FDA QMSR require…
Internal audits are a fundamental component of any quality management system. Whether required by ISO 13485, ISO 9001, or customer-specific expectations, internal audits provide a structured opportunity to evaluate how well your quality system is performing in practice — not just on paper. Why Internal Audits Matter Internal audits serve multiple purposes within a regulated organization: Compliance verification: Confirming…
The FDA’s transition from the Quality System Regulation (QSR) under 21 CFR Part 820 to the Quality Management System Regulation (QMSR), which aligns with ISO 13485:2016, represents one of the most significant regulatory shifts for medical device manufacturers in recent years. What Is Changing? The QMSR replaces the prescriptive requirements of 21 CFR Part 820 with a framework that…
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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