The biggest regulatory change in the US market in years
With the introduction of the Quality Management System Regulation (QMSR), the previous QSR (21 CFR Part 820) is replaced. Since 2nd February 2026, new requirements have been in force, with a direct link to ISO 13485:2016.
What does this mean in concrete terms for manufacturers of medical devices? Which processes need to be adapted? And how do you prepare for the new FDA inspection regime in a structured way?
In this compact eLearning, you will receive a well-founded and practical overview of the background, content and effects of the QMSR, clearly structured, regulatorily sound and directly implementable.
Why should you choose our eLearning course?
Up-to-date & regulatory-based
You will receive a structured overview of the QMSR including FDA-specific requirements, transitional regulations and regulatory context.
Clear comparison QSR vs. QMSR
We show you transparently,
- what remains the same,
- what is omitted,
- which is exacerbated,
- and what new requirements are being added
Practice-oriented implementation
Using concrete examples from Design Control, CAPA, Supplier Management and Post Market Surveillance, you will learn how existing processes need to be adapted.
Preparing for FDA Inspections
You will learn how the inspection program is changing (replacement of QSIT) and which documents will be more in focus in the future.
Interactive & flexible learning
Work through the content at your own pace, with practical examples, decision questions and compact summaries.
Certificate included
After successful completion, you will receive a certificate of qualification for QMSR.
- Content
- Introduction to QMSR and Scope
- Background and regulatory context
- Entry into force and transitional period
- Objectives of the QMSR: Harmonization with ISO 13485
- Relevance for medical device manufacturers
- Interfaces to EU MDR/IVDR
- Structure and Core Requirements
- ISO 13485:2016 “by reference” – what does it mean?
- Critical chapters (Risk Management, Design & Development, PMS)
- FDA-Specific Supplements
- New terms and concepts (e.g. Medical Device File instead of DMR)
- Requirements for life-supporting products
- Special features for software and AI-based medical devices
- Comparison QSR (old) vs. QMSR (new)
- Design Controls
- CAPA
- Complaint Handling
- Supplier Controls
- Practical implications for existing SOPs and documentation
- Special features for ISO 13485 certified manufacturers
- Inspections & Regulatory Expectations
- New Inspection Program (Compliance Program 7382.850)
- What documents the FDA will be able to view in the future
- Typical findings and preparation options
- Self Inspections & Mock Audits
- Roadmap for implementation
- Conducting a gap analysis
- Prioritization and scheduling
- Adaptation of QM system, SOPs and IT tools
- Training of key roles
- Sustainable anchoring in the company
- Final examination and certificate
- Introduction to QMSR and Scope
- How you benefit
- You understand the regulatory background and goals of the QMSR.
- You can see which processes in your company are affected.
- You can safely distinguish between QSR and QMSR requirements.
- You know how to prepare your QM system for the new requirements in a structured way.
- You’ll be prepared for future FDA inspections.
- Methods
- Concise trainer inputs
- Interactive elements, examples & decision trees
- Practical checklists & do/don’ts
- Quizzes
- Target Audience
- Regulatory Affairs
- Quality Management
- Development & Project Management
- Production & Operations
- Purchasing & Supplier Management
- Clinical / Post Market Teams
- Management and Management
