Training Features

Navigating the Transition to FDA QMSR

Bridge the gap between international standards and U.S. law with this expert-led roadmap to the FDA’s new "FDA-Plus" regulatory model.
Format

E-Learning

Level

Intermediate

Trainer

René Schings

Exam

Exam and certificate included

Duration

1 hour
6 modules

Price

€ 195 or equivalent currency

The FDA QMSR Transition: Moving from QSR to ISO-Based Compliance

The U.S. medical device regulatory landscape is undergoing its most significant transformation in over 25 years as the FDA replaces the legacy Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR). By incorporating ISO 13485:2016 by reference, the FDA is moving toward global harmonization, creating an "FDA-Plus" model that merges international standards with critical U.S. statutory requirements.

Why This Training is Essential

With the mandatory compliance deadline of February 2, 2026, manufacturers must evolve their systems to meet these new enforceable standards. This transition is not a simple paperwork update; it requires a fundamental shift in how organizations handle:
  • Terminology: Mapping legacy concepts like the Device Master Record (DMR) to the new Medical Device File.
  • Risk Management: Moving from isolated risk analysis to ''Risk-Based Thinking'' that permeates every process across the total product lifecycle.
  • Inspection Transparency: Preparing for the removal of the "shelter" clause, which now gives FDA investigators explicit authority to review internal audits and management review records.
Whether your firm is currently QSR-based, ISO-certified, or dual-compliant, this training provides the technical expertise and strategic roadmap necessary to navigate these structural changes and ensure uninterrupted market access.
What You Will Learn
Who Should Attend?
What is Included?
Course Details
  • Identify differences between the requirements of the QSR and QMSR and/or ISO13485 and the QMSR 
  • Understand different dynamics between QMSR audits and QSR inspections 
  • Perform a GAP analysis in the existing QMS 
  • Evaluate the impact on the current QMS 
  • Plan strategic next steps for ongoing projects and running processes.  
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Duration: Approx. 1 hour.
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
This training is designed for professionals in the Medical Device and In Vitro Diagnostic (IVD) industries to understand the changes that the introduction of the QMSR in February 2026 brings along for their existing Quality Management System which complied to the QSR,
ISO 13485 or both, specifically:
  • Regulatory Affairs (RA) & Quality Assurance (QA) professionals 
  • Middle and Senior Management 
  • Product Development, Procurement and Production Engineers.
It is assumed that the trainees have a thorough understanding of and/or are experienced in ISO 13485. If not so, or for those that are “rusty” on the ISO requirements, they might consider first doing a ISO 13485 training.

Comprehensive Regulatory Expertise

By integrating specialized knowledge of the 2026 transition into a flexible, 60-minute curriculum, this course empowers professionals to lead their organizations through the "Risk-Based Pivot" and new FDA inspection dynamics while advancing their regulatory careers.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

René Schings

René, with over 20 years of management experience in Quality Management, Research & Development, and more, serves as a lead auditor at Qserve, specializing in ISO audits, and brings expertise in building QMS for start-ups, managing complex change projects, and overseeing multi-site, multi-cultural teams, having previously held senior positions in the Medical Device and Consumer Electronics industries.
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