Validate your knowledge about Quality and Regulatory requirements with our medical device quizzes.
You will learn about various topics pertaining to ISO 13485:2016, FDA 21 CFR 820, Risk Management, Quality Manufacturing, Design and Development, and more….
These quizzes are aimed at building your knowledge via bits and bytes – providing quick bursts of training and feedback in each subject area. This is a great alternative to boring lectures and training programs.
The FDA has transitioned from QSR to QMSR, and the latter is in force starting February 2nd. 2026. Want to checkout our latest QMSR and ISO 13485 Essentials Quiz? Click here! If you score >85% you can earn a Certificate of Achievement.
We know this approach is quite effective if the quizzes are repeated over time (they are kept short – 5 to 10 questions so you can take them whenever you find even small windows of time). One of the research studies that demonstrates their impact on learning can be found using the link below: https://www.sciencedaily.com/releases/2020/09/200917180410.htm
As such, we recommend you take these quizzes as many times as you like. The questions are drawn from a large bank that covers medical devices design, manufacturing, quality, regulatory, document control, and servicing. Both the questions and answers are presented in random order.
Click on any topic below to get started:
QMSR and ISO 13485:2016 Essentials (earn your Certificate of Achievement when you score >85%)
IEC 62366 – Usability Standard
Statistical Process Control – SPC
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