QMSR Is in Effect: What IVD Manufacturers Still Need to Do

In this episode, Emily Friedland, VP of Clinical Research at DCN Dx, talks with two guests who come at QMSR from different directions: the regulatory strategy side and the quality systems implementation side. Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, covers the regulatory framing: what changed with the QMSR transition, how to map an ISO 13485-based QMS against QMSR’s U.S.-specific requirements, and what FDA’s updated inspection approach under CP 7382.850 means for how teams document and maintain QMS records. Kevin Gunning, Principal Consultant at Gunning Quality Systems LLC, brings the quality systems implementation perspective: what it takes to build and maintain a QMS that holds up under QMSR, how organizations should think about the practical work of a gap assessment and remediation, and what teams with established ISO 13485 systems often overlook when they assume the transition is “mostly handled.” Kevin has spent more than 25 years implementing and managing quality systems at IVD and medical device companies, and has extensive firsthand experience on both sides of FDA and ISO audits and inspections. Together, Dan and Kevin cover the four gap areas that matter most for IVD manufacturers, what FDA can now request during an inspection that was previously off-limits, and how to scope a proportional remediation effort. Read the companion article here: https://dcndx.com/insights/qmsr-ivd-manufacturers-gaps-iso-13485/