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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.

4.8(0 reviews)

1.5 hours

Instructor

John E. Lincoln

FDA Regulatory Affairs, Design Control & QMS Expert

FDA Inspections After QMSR: What Replaces QSIT 2.0 — The New Inspection Reality

Quantity

Recording – 1 Viewer

$390.00

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Secure payment via Stripe

Certificate of completion

What You'll Learn

Introduction to the QMSR and the incorporation by reference of ISO 13485

The new 21 CFR 820 "plus" — key changes and major areas of emphasis

Why there is no QSIT 2.0 and what replaces it in FDA inspections

Incorporation of risk management throughout the quality system based on ISO 14971

The shift from QSIT subsystem model to a process-focused inspection approach

Managing the hybrid compliance burden between legacy QSR and new ISO-based QMSR

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

Introduction to the QMSR and ISO 13485 Incorporation by Reference

15 min

The New 21 CFR 820 "Plus" — Key Changes and Emphasis Areas

15 min

Risk Management Throughout the QMS — ISO 14971 Integration

12 min

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.

40+ Years FDA Regulated Industries30 Years Independent ConsultantUCLA GraduateDesign Control & Technical File Expert

Quantity

Recording – 1 Viewer

$390.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

Topics

QMSR 21 CFR 820 ISO 13485 FDA Inspection Medical Device QSIT Regulatory Affairs

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