Level up your medical device skills, grow your career and get your medical device to market faster!

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What is the Medical Device University?

A large and growing E-Learning library with more than 250 on-demand courses.

Templates for all the technical documentation you need.

A turnkey Quality System, compliant with ISO 13485:2016 and FDA 21 CFR Part 820.

Self-Assessments and Course Completion Certificates.



From quick, hands-on lessons to comprehensive certifications, you'll learn everything you need to know to stay current in the medical device industry.



Spend less time studying regulations. Spend less money on expensive consultants. Get your product to market sooner.

Explore Our Courses

7 Reasons to join the Medical Device University


Ready-to-use Templates

We’ve done most of the work for you. Choose from more than 150 templates that cover all your technical documentation needs.


On-demand courses

Over 250 on-demand courses covering regulatory processes from beginning to end, so you’ll know exactly what to do every step of the way.


Turnkey Quality System and Support

We provide resources and support to develop a lean and legally compliant quality system to make sure you’ll pass audits and inspections related to FDA regulations and ISO 13485.


Avoid Costly Consultants

Increase your knowledge base and acquire the resources you need to be competent and confident in the face of audits and inspections.


Learn from the best

Industry best practices and actionable training from our senior experts.


Up-to-Date Information and Support

We regularly update the MDU as information and regulations change, and provide fast one-on-one support. If you have a question, we are there for you.


Save money

The Quality System and technical documentation templates included in the MDU can cost over $30,000 elsewhere. The MDU brings everything under one roof and lets you save big.

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