FDA Inspections After QMSR: What Replaces QSIT 2.0 — The New Inspection Reality
Understand the new QMSR inspection reality — what replaces QSIT, how FDA will inspect under ISO 13485 alignment, and how to manage the hybrid compliance burden of QSR + QMSR.
Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
What You'll Learn
About the event
About this event
The US FDA has published the QMSR to replace the previous QSR, with an implementation deadline of February 02, 2026. The Quality Management System Regulation (QMSR) revises 21 CFR 820 to include ISO 13485:2016 by reference. For FDA inspections, there is no QSIT 2.0 on the way.
Instead, FDA inspections will transition to a process aligned with ISO 13485, described in the Medical Device Compliance Program. This represents a shift from QSIT's subsystem model to a process-focused inspection approach, a heavier emphasis on risk management, and a hybrid compliance burden between legacy QSR requirements and new ISO-based expectations.
Code: MD1857
Curriculum
Requirements
- Senior management, QA, and Regulatory Affairs in medical device and combination product companies
- Applicable to product development teams, engineers, consultants, and operations personnel
Meet Your Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
John E. Lincoln has over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment including QMS and software validations, ISO 14971 product risk management files/reports, Design Control/Design History Files, and Technical Files. He has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). John has prior experience in military, government, electronics, and aerospace industries. He is a peer-reviewed author, teacher, and speaker, and a graduate of UCLA.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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