QMSR (21 CFR 820)
21 CFR Part 820 — QMSR
FDA Quality Management System Regulation
About this course
Course overview
The amended Part 820 incorporates ISO 13485:2016 by reference and replaces the QSR from 2 February 2026. Covers the structure of the QMSR, key differences vs. ISO 13485, and how to transition a QSR system.
At a glance
Key information
20 modules
Quality Management
80%
Free, instant
U.S. medical device manufacturers, importers and specification developers preparing for the QMSR compliance date.
Outcomes
What you'll learn
- Understand from QSR to QMSR
- Understand key Definitions and Differences vs. ISO 13485
- Understand transitioning a QSR System to the QMSR
- Understand design Controls Under the QMSR
- Understand medical Device Reporting (21 CFR Part 803)
- Understand corrections, Removals and Recalls (Part 806 and Part 7)
- Understand unique Device Identification (21 CFR Part 830)
- Understand electronic Records and Signatures (21 CFR Part 11)
Curriculum
Course curriculum
20 modules · Tap any module to expand and preview lessons.
Benefits
Why take this course
Build a compliant QMS
Translate ISO requirements into practical procedures, records and controls for your organisation.
Stay audit-ready
Understand the exact clauses and expectations auditors and regulators check during inspections.
Boost your career
A recognised certificate of completion that you can add to your CV and LinkedIn profile.
Plain-language modules
Complex requirements broken into bite-sized, easy-to-remember lessons with examples.
Free assessment & certificate
Take the timed exam and earn a personalised, verifiable certificate at no cost.
Who it's for
Target audience
- U.S. medical device manufacturers, importers and specification developers preparing for the QMSR compliance date
Included
What's included
20 plain-language modules
Bite-sized lessons with examples, memory aids and key terms.
Timed assessment
Multiple-choice exam with 80% pass mark. Retake anytime.
Verifiable certificate
Personalised PDF with a unique verification code — shareable on LinkedIn.
Downloadable resources
Reference material and attachments available inside modules.
Lifetime access
Learn at your own pace — revisit modules whenever you need to refresh.
Aligned to standards
Content mapped to internationally recognised medical device standards and regulations.
FAQ
Frequently asked questions
More questions? Visit the full FAQ.
Free · Lifetime access
Exam + certificate included