ISO 13485:2016 /
FDA 21 CFR Part 820
QMS Training
(Fundamentals)
What's included
We provide you with all the resources necessary to fully understand the ins and outs of ISO 13485:2016 and FDA 21 CFR part 820.
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Learning Content
8 lessons with with engaging video content and downloadable transcriptions of all the information covered in the lesson. Approx. 8 hours
Assessments
Each lesson is concluded with an assessment and there is a final exam at the end that covers the entire course.
Certificate
Complete all of the lessons and pass the final exam to receive a personalized certificate.
Live Instructors
Have a question? Feel free to ask us anything in the form at the end of every lesson and we will answer it ASAP.
ISO 13485:2016 /
FDA 21 CFR Part 820 QMS Training(Fundamentals)
An essential course for all medical device professionals.

Our Approach
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What our learners are saying
"As someone who is newer to the medical device world...
I felt that this training allowed me to understand the complex subjects by breaking down lengthy and complicated statements and applying them to real-world scenarios. I liked that the regulations were available during the training, but weren't read to me in a lecture format. The training used graphics that kept my attention and used relatable situations that allowed me to picture how this would actually be useful in my day-to-day life. Overall, I would definitely recommend it to anyone needing a refresher or to someone newer in this industry!"
C.C.
C.C.
"The ISO 13485 training was very user friendly and easy to follow...
Each section was very informative and thoroughly explained each topic in a manner that was easy to understand. This training made a dry topic interesting and was interactive by asking questions to check comprehension of each topic. Overall, I would recommend this training to anyone seeking an in-depth understanding of ISO 13485 or FDA QMS."
K.H.
K.H.
Our Approach
Lesson Preview
Course Lessons
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