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Free course template · US federal

Medical device design and development controls under the FDA QMSR

A ready-made course, live deck and two surveys for engineering and quality teams. AhaSlides tracks progress, completion and scores for you. 20 minutes, 4 lessons, 10-question final check. Last reviewed 6 November 2026; not legal advice.

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Course outline at a glance

  • The evidence
  • How it became a requirement
  • Accordion
  • Quiz
  • Sorting activity

  • Who must comply
  • Planning, risk and inputs
  • Quiz
  • Process
  • Scenario

  • Outputs, review and verification
  • Validation, transfer and changes
  • Flashcards
  • Quiz
  • Sorting activity
  • Accordion
  • Multi-select quiz

  • Final assessment
  • Course complete
  • Quiz
  • Flashcards

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.

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Completion is tracked for you

Learners sign in to take the course, so every start, finish and score is recorded in AhaSlides. No spreadsheet to keep.

  • Who has finished

    See who has not started, who is in progress and who has completed the course.

  • Every score

    Each learner's result on the 10-question final check, against the 80% pass mark.

  • What landed

    Survey results show what people took away and what to change next time.

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4 lessons, about 20 minutes

What learners can do at the end of each lesson. Minutes are an estimate.

  • Lesson 1: Why design controls matter · 7 min

    Before you begin · The evidence · How it became a requirement

  • Lesson 2: What the QMSR requires · 5 min

    Who must comply · Planning, risk and inputs

  • Lesson 3: Stages in action · 4 min

    Outputs, review and verification · Validation, transfer and changes

  • Lesson 4: Final assessment · 4 min

    Final assessment · Course complete

Source and credit: Quality Management System Regulation (QMSR) - Design and Development, US Food and Drug Administration (CDRH), www.fda.gov/media/189041/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 rewritten as an interactive course and live session, with activities and quizzes added.

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Often taught together

Courses teams often run alongside this one.

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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).

Engineering and quality teams at medical device organisations, including R&D.

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
Then edit anything else you like: wording, scenarios, your logo.
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Ready to run it?

Free. Copy the course, live deck and both surveys into your AhaSlides account in one click.

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