ISO 13485:2016 /
FDA 21 CFR Part 820
QMS Training
(Fundamentals)

An essential course for all medical device professionals. 

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

What sets this course apart from the other ISO 13485 training courses out there? Watch this video to learn about our vision for medical device training. 
Write your awesome label here.

Lesson Preview

No one wants to click through hours worth of boring text. That's why we designed this course to be engaging and entertaining, while still familiarizing you with all the information you need. 
Write your awesome label here.

What our learners are saying

Our Approach

What sets this course apart from the other ISO 13485 training courses out there? Watch this video to learn about our vision for medical device training. 
Write your awesome label here.

Lesson Preview

No one wants to click through hours worth of boring text. That's why we designed this course to be engaging and entertaining, while still familiarizing you with all the information you need. 
Write your awesome label here.

Course Lessons

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