Medical Device Postmarket Convergence: New FDA and EU Lifecycle Expectations
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Webinar - Link will be emailed to attendees on the morning of the event.
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Registration is required before Wednesday, April 29, 2026 at 11:30 AM
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About this event
TOPIC: How QMSR and EU MDR align the IMDRF vision for medical device postmarket systems
TOPIC DESCRIPTION: This session examines how medical device regulators are moving toward a more integrated, risk-based lifecycle model for quality and postmarket oversight. While QMSR incorporates ISO 13485:2016 as the quality system framework, the broader driver of regulatory convergence is the IMDRF, whose ongoing work has helped shape global expectations for structured data, harmonized terminology, reportability logic, and connected regulatory decision-making. The FDA’s adoption of QMSR and its new risk-based inspection approach, which is already issuing Observations on these themes, reflects that larger movement toward a more modern, globally aligned, and harmonized medical device quality management system.
The presentation will connect those U.S. developments to the existing EU MDR expectations for postmarket surveillance and vigilance, including PMS reporting, vigilance reporting decision-making, vigilance trend reporting, and the assumption that product risk is continuously reassessed using postmarket information. It will also briefly address the connection of clinical information to PMS/PSUR, PMCF, and product risk, emphasizing that regulators increasingly expect continuous monitoring, systematic data collection, integrated analysis, early trend detection, and closed-loop links between complaints, surveillance, risk management, CAPA, and product improvement across the medical device lifecycle. That connected-system framing is consistent with both guidance from IMDRF and emerging inspection data from FDA since the advent of QMSR. Meeting these goals is no longer possible without tools that bring device lifecycle data into a closed-loop, AI-enabled system. All of this has implications for the premarket side of MedTech commercialization.
Attendees will leave with a practical understanding of how to interpret these developments not as separate U.S. and EU obligations, but as part of a converging global expectation for an integrated medical device quality management system and postmarket surveillance system that can support defensible reporting decisions, earlier signal detection, stronger inspection readiness, and better lifecycle management and control.
SPEAKER: Christine Zomorodian
SPEAKER BIOGRAPHY: Christine Zomorodian is Chief Regulatory Intelligence Officer at empowerreg-ai, where she leads domain strategy, providing thought leadership at the intersection of global regulatory science, AI, and digital health innovation. With an MS from UW BRAMS and over 30 years in life sciences, healthcare, medtech, and software, she brings deep industry expertise and a proven record of predictive insight and innovation. She founded Gish Consulting in 2010, advising and supporting clients from startups and small firms to Fortune 500s for quality and regulatory needs. Over her career, Christine developed breakthrough clinical bioassays, earned multiple excellence awards, managed global CAPA programs, and built QMS programs for ISO 13485 certification, including Microsoft Health Solutions. She continues to teach and speak on innovation in regulatory compliance.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied towards re-certification /continuing education from the following organizations:
| 1.5 pts |
RAC recertification from RAPS |
| 1.5 CEUs |
CCRP recertification from SOCRA |
| 1.5 CEUs |
CIP recertification from PRIM&R |
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This webinar will be recorded.
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