Lesson 1: Why the rule changed · 7 min
Before you begin · From the 1996 rule to the QMSR · Compare the two rules
Three pieces that work together
Learners prepare on their own, you answer questions live, and the surveys tell you what stuck. 2 fields to fill in with your own policy, contacts and locations; each one is highlighted inside the course.
What would you do?A small company only sterilises devices for other firms under contract. The owner says the QMSR does not apply because the company never designs anythingCheck the role: contract sterilisation counts as a manufacturing-related function, so a quality system suited to that role is expectedAgree: no design means no quality system is neededWait for an inspector to confirm first
Live deckQuiz · 4 slidesContent · 2 slidesWord cloud · 1 slideScale · 1 slide
Feedback surveyHow much do you agree with each statement? I can:How familiar are you with the QMSR?What do you most want to get from this course?Overall, how would you rate this course?
6 lessons, about 30 minutes
What learners can do at the end of each lesson. Minutes are an estimate.
Lesson 2: Purpose and scope · 5 min
What the QMSR is for · Who and what it covers
Lesson 3: Standards and definitions · 5 min
Incorporation by reference · Which definition wins?
Lesson 4: Records, labelling and what stayed · 5 min
Where the rule adds to the standard · Labelling checks in practice
Lesson 5: Inspections and getting ready · 4 min
What changes for inspections · Adapting to the change
Lesson 6: Final assessment · 4 min
Final assessment · Course complete
Source and credit: Overview of the Quality Management System Regulation, Navigating the Quality Management System Regulation and the QMSR Key Takeaways webinar, US Food and Drug Administration (CDRH), www.fda.gov/media/181434/download (opens in a new tab). A US government work in the public domain. US Food and Drug Administration (CDRH) does not endorse AhaSlides. Adapted by AhaSlides: the training slides and webinar transcript rewritten as an interactive course and live session, with activities and quizzes added.
Often taught together
Courses teams often run alongside this one.
Ethics & Compliance Training
Anti-money laundering & Bank Secrecy Act (opens in a new tab)
Ethics & Compliance Training
OFAC sanctions compliance (opens in a new tab)
Ethics & Compliance Training
Know your customer / customer identification program (opens in a new tab)
Common questions
Yes. The course, the live deck and both surveys are free. Claiming the template into your AhaSlides account is free too.
Yes. The course is self-paced and online, and the live deck lets you add a live session in the room or online.
At onboarding or as continuing professional development, with a yearly refresher (best practice).
Quality and regulatory teams at medical device organisations.
Record completion in your own LMS or record system, so you can show who finished the course and when.
Yes, everything. Change the wording, swap scenarios for ones from your workplace, add your logo, or remove parts that don't apply.
Your own details, each highlighted inside the course:
- Link to your live session deck
- Link to the self-paced course