US FDA QMSR
New FDA 21 CFR 820 Quality Management System Regulation for medical devices.
Don’t Risk Non-Compliance! Train on US FDA QMSR, or Quality Management System Regulation
The FDA has issued the final rule for the Quality Management System Regulation (QMSR), replacing the long-standing Quality System Regulation (QSR). This new regulation impacts all medical device manufacturers in the U.S. Without proper preparation, your company could face inspection or compliance penalties. Get ahead with expert training designed to simplify the changes and guide you to compliance.
Time is Running Out!
The deadline is quickly approaching—your team must be QMSR-ready by February 2, 2026 to avoid non-compliance. Don’t let time slip away and risk costly delays
Mistakes are Costly
Non-compliance risks FDA 483 observations, failed customer audits, and legal consequences that could hurt your bottom line.
The Industry is Changing
The FDA’s shift to QMSR is complex. Many companies don’t even know the rules have changed.
What are the Key Changes from QSR to QMSR?
Goodbye to Quality System Regulation. The title for 21 CFR 820 will be changed to Quality Management System Regulation (QMSR).
FDA will Incorporate by reference ISO 13485:2016 Quality Management System requirements into 21 CFR 820.
The FDA will also incorporate by reference ISO 9000:2015 clause 3, Definitions. These are necessary for the application of ISO 13485:2016. The FDA also included additional definitions in the QMSR, as terms and definitions matter to the FDA, and they should matter to you.
The FDA will add new requirements to 21 CFR 820 that will supplement ISO 13485:2016 in order to align with Food, Drug, and Cosmetic Act requirements for medical devices. These include additional requirements for the quality management system, control of records, and labeling and packaging controls. This means that following ISO 13485:2016 alone is insufficient to comply with the new Quality Management System Regulation.
The Current 21 CFR 820 QSR is Going Away!
ISO 13485:2016 is no Longer Voluntary!
ISO 13485:2016 will no longer be a voluntary standard to the U.S. FDA. It will be a regulation that the FDA can and will enforce, including the ISO 13485 requirement for risk management throughout the product lifecycle and quality systems.
3 Options to Get QMSR-Ready
Choose one of these options to get ready for QMSR, depending on your needs at this time.
Introduction
Want to learn more about QMSR? Build awareness about the Quality Management System Regulation.
Intended audience:
- QA/RA professionals
- Executives
You’ll get:
- 8-minute video
- Glossary of QMSR terms and definitions for medical device companies
Free
Implementation Training
Understand the key changes from QSR to QMSR, identify how they impact your organization, and learn actionable steps to stay compliant. Afterwards, you can decide to implement what you’ve learned with our downloadable tools or let us implement it for you.
Intended audience:
- Quality leaders
- Quality management representatives
- QA/RA professionals
- QMSR implementation teams
You’ll get:
- Comprehensive 1-hour online training
- Interactive quizzes
- US FDA QMSR Final Rule
- ISO 13485:2016
- ISO 9000:2015 definitions section
- Quality plan template
- Gap analysis template
- Glossary of QMSR terms and definitions for medical device companies
- Certificate of completion
- Expert insights
- 10-step implementation process
- 30-day money back guarantee
$199
Note: price is per person
Let Us Implement For You
Our experienced QMSR consultants can implement QMSR at your company. Select our package QMSR implementation deal if you are a small to medium sized company who are already ISO 13485:2016 compliant. If you are a large company, or not currently ISO 13485 compliant, contact us for consulting services.
Intended audience
- This package deal is intended for small to medium sized medical device companies who are already ISO 13485:2016 compliant.
You’ll get:
- Management awareness tools
- Implementation training for 2 people, with interactive quizzes and certificate of completion
- US FDA QMSR Final Rule
- ISO 13485:2016
- ISO 9000:2015 definitions section
- Glossary of QMSR terms and definitions for medical device companies
- Completed quality plan
- Completed gap analysis
- QMSR updates to 30 standard operating procedures (SOPs)
- QMSR updates to up to 10 forms or templates
- QMSR updates to quality manual
- Expert insights
- QMSR employee awareness training (GMP training) for 20 people, with interactive quizzes and certificate of completion.
$19,900
Meet The Experts
We are a passionate team with over 40 years of combined experience at dozens of medical device, pharmaceutical and life science companies across the U.S.
Michael Bubien
Michael is a Pharmaceutical / Medical Device consultant with over 20 years of industry experience and extensive knowledge QMSR. He has implemented new quality management systems at multiple companies.
Kathleen Miller
Kathleen is a results-driven consultant with over 20 years experience in Quality Systems & QA. She is an experienced trainer and quality management representative. Kathleen is implementing QMSR for her medical device clients.
Get QMSR ready with our QMSR Implementation Training
- Comprehensive Training: One hour of expert-led videos designed to simplify QMSR compliance.
- Interactive Quizzes: Reinforce your understanding and ensure you’re ready to implement what you’ve learned.
- Downloadable Tools:
- US FDA QMSR Final Rule
- ISO 13485:2016
- ISO 9000:2015 Definitions Section
- Quality Plan template
- Gap Analysis Template
- Consolidated Glossary of Terms and Definitions for Medical Devices
- Certificate of Completion: Certificate of course completion upon 80% pass of final quiz, to demonstrate training and competence in QMSR.
- Expert Insights: Gain practical advice from a seasoned quality management professional with years of industry experience, including our 10-step process to implement QMSR at your company.
Course Outline
- Welcome to the course
- Overview and scope of QMSR final rule
- Combination products
- Incorporation by reference
- Terms and definitions
- Overview of ISO 13485:2016
- Requirements for QMS
- Control of records
- Device labeling and packaging controls
- Regulatory considerations
- Implementation steps
- Review and wrap-up
Intended Audience
- Quality Leader
- Quality Management Representative
- Quality Assurance Professionals
- Regulatory Affairs Professionals
- QMSR Implementation Teams
Money Back Guarantee!
Includes our 30 Day Money Back Guarantee!
Your Investment
$199
Compare this to the cost of failed FDA inspections, customer audits or compliance penalties for adulterated product. This training is a small price to pay.