Test yourself and learn about Quality and Regulatory requirements for Medical Devices with short focused 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….
The 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.
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:
IEC 62366 – Usability Standard
Statistical Process Control – SPC
Book mark this page and share with others to help them as well. We would love to hear from you – please write to us at: info@thekpisystem.com or call (512) 560-8326
NOTE on QMSR – merging of ISO 13485 and QSR: As of Jan 2024 there is a move by the FDA to update 21 CFR 820 QSR and harmonize it with the ISO 13485 Standard. If you would like to learn more on the same and hear updates from us, or would like a custom quiz designed for your needs please contact us at: info@thekpisystem.com.