Select live individual access, corporate group access, or 12-month recorded access.
$499
Save $200You get one log-in for the virtual seminar for one participant, presentation materials, 3 hours of Continuing Education certificate, and the opportunity to ask questions by phone and email.
$1,499
Save $500You get 5 log-ins for the live full virtual seminar for all participants, presentation materials, 3 hours of Continuing Education certificate, and the opportunity to ask questions by phone and email.
$498
Save $200You'll have single user access to log-in for an archived recording of the entire virtual seminar for 12 months, including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording, 3 hours of Continuing Education Certificate and transcript for the entire session. Delivery is approximately 48 hours after the session.
All options include presentation materials. Live options include the opportunity to ask questions by phone and email.
A simple, focused agenda covering the QMSR transition, ISO 13485 alignment, and FDA’s new inspection approach.
Opening remarks and overview of the session structure.
A short break before the second session.
Final takeaways and live question-and-answer discussion.
A practical 3-hour overview of the QSR to QMSR transition, ISO 13485 alignment, and FDA’s new inspection expectations replacing QSIT.
The U.S. FDA’s transition from the legacy Quality System Regulation, QSR, to the new Quality Management System Regulation, QMSR, represents one of the most significant regulatory changes impacting the medical device industry in recent years.
With FDA aligning 21 CFR Part 820 more closely with ISO 13485:2016 and replacing the traditional QSIT inspection approach with the new FDA Device Inspection Manual 7382.850, medical device manufacturers must understand how these evolving requirements will affect their Quality Management Systems, inspection readiness strategies, and ongoing compliance obligations.
This 3-hour live webinar provides a practical overview of the new FDA QMSR framework, the relationship between QMSR and ISO 13485:2016, and the inspection expectations associated with FDA’s updated inspection model.
The seminar will also discuss FDA’s increasing emphasis on risk-based compliance oversight, patient and user safety, ISO 14971 risk management integration, and Human Factors / Usability Engineering expectations under the evolving regulatory framework.
Principal of J. E. Lincoln and Associates LLC | 36+ years of FDA-regulated industry experience
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years of experience in U.S. FDA-regulated industries, including 22 years as an independent consultant. He has worked with companies from start-up to Fortune 100 across the U.S., Mexico, Canada, France, Germany, Sweden, China, and Taiwan. He specializes in quality assurance, regulatory affairs, QMS remediation and FDA responses, 510(k)s, validations, ISO 14971 risk management files, Design Control / Design History Files, Technical Files, CAPA systems, and analysis.
