What changes for IVD developers and manufacturers now that the FDA Quality Management System Regulation is in force, and where the gap work tends to land.
FDA’s Quality Management System Regulation (QMSR) took effect on February 2, 2026, incorporating ISO 13485:2016 by reference into 21 CFR Part 820 and replacing the legacy Quality System Regulation. For IVD developers and manufacturers, the change is more than a paperwork exercise. The updated inspection approach expands what FDA investigators can request, and certain records that were previously out of scope are now reviewable.
In this episode of Expert Insights, Emily Friedland, VP of Clinical Research at DCN Dx, talks with two guests who come at QMSR from different sides of the same problem. Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, walks through the regulatory framing: what changed with the transition, how to map an ISO 13485-based QMS against QMSR’s U.S.-specific requirements, and what FDA’s updated inspection approach means for how teams document and maintain QMS records. Kevin Gunning, Principal Consultant at Gunning Quality Systems LLC, brings the quality systems implementation perspective from more than 25 years of building and maintaining QMS programs at IVD and medical device companies. Together, Dan and Kevin cover the four gap areas that matter most for IVD manufacturers, what FDA can now review that was previously off-limits, and how to scope a proportional remediation effort without overbuilding the QMS.
For more detail, read Dan’s companion article: [QMSR Readiness for IVD Manufacturers: Where Well-Maintained ISO 13485 Systems Still Have Gaps]
Listen below, or find us on your favorite podcast platform.
What You’ll Hear in This Episode
1. What QMSR changed from the legacy Quality System Regulation, and what it means for IVD teams day-to-day
2. Why a documented QMSR gap assessment still matters even for organizations already certified to ISO 13485
3. How to put together a Quality Plan that management will sign and that demonstrates readiness to outside auditors and FDA investigators
4. The four gap areas where well-maintained ISO 13485 systems most often fall short under QMSR: applicable regulatory requirements (UDI, MDR, corrections and removals); complaint handling records; labeling and packaging controls, including conformance to 21 CFR Part 809 for IVDs; and definitions and terminology
5. What FDA’s updated inspection approach under CP 7382.850 means for risk-based decision-making and how risk management files become a roadmap during inspection
6. Which records are now within FDA’s inspectional authority under QMSR that previously were not, including management review minutes, internal quality audits, and supplier audit reports
7. The most common misconceptions Dan and Kevin see from teams who assume the QMSR transition is “mostly handled” because they hold ISO 13485 certification
About the Guests
Emily Friedland | VP of Clinical Research, DCN Dx (Host)
Emily leads clinical research at DCN Dx and is a guest host of Expert Insights, the company’s podcast for diagnostics professionals.
Dan Simpson | Director of Regulatory Affairs, DCN Dx
Dan works with IVD developers and manufacturers on FDA and global regulatory strategy and inspection preparation. He holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and is the author of DCN Dx’s article on QMSR readiness for IVD manufacturers.
Kevin Gunning | Principal Consultant, Gunning Quality Systems LLC
Kevin is a quality systems executive with more than 25 years of experience in IVD, medical device, and pharmaceutical industries. He has built quality management systems from the ground up at multiple organizations under ISO 13485 and 21 CFR Part 820, and has extensive experience both hosting and conducting FDA and ISO inspections and audits. He holds the Certified Quality Auditor (CQA) credential from the American Society for Quality (ASQ) and previously served as Vice President of Quality Assurance at Alveo Technologies, an IVD company, before founding Gunning Quality Systems LLC.
