The fastest and easiest way to get your medical device approved.

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Medical Device University provides access to comprehensive courses, precise instructions, and proven templates to create the documents you need. 

 

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

What is the Medical Device University?
 

A large and growing E-Learning library with more than 150 video lessons.

Templates for all the technical documentation you need.

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

Case Studies

"After our last FDA inspection, we had to fix several findings very quickly. Using the MDU, it was pretty easy to add the missing procedures to our quality system and create the missing technical documentation for one of our devices." - Quality Manager, Michel Bazemore, Biomed pharmaceuticals inc.

"With the Medical Device University, we were able to establish our quality system within only four weeks. Two weeks later, we had the notified body auditing with only one minor finding." - CEO, Mike Swinford, power medical inc. 

7 Reasons to join the Medical Device University

1.

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.

2.

Instructional Videos

We have over 150 training videos covering regulatory processes from beginning to end, so you’ll know exactly what to do every step of the way.

3.

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.

4.

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.

5.

No Re-Audits

We can help you avoid the costly re-audit process, to save money and protect your product launch timeline.

6.

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.

7.

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.

Still not convinced?

Have a look at one of our training videos to convince yourself of the quality of MDU

What's new?

Quality Management (ISO 13485)

This course will help you accomplish the following goals: establish an ISO 13485 and FDA-compliant Quality Management (QM) system create a QM manual with the necessary policies and objectives * Identify processes and formulate standard operating procedures (SOPs) repare your QM system for internal and external audits If that sounds like a lot, it is! But Medical Device University and the J ...

Quality Management (ISO 13485)

FDA-approval

FDA task series Your path to FDA approval: Welcome to our FDA approval course. You will have your first FDA filing file in your hands by the end of this course. Start right away with the first video. Our FDA expert Luca Salvatore will guide you through this course.

FDA-approval

An introduction to the legal system according to MDR

If your product is classified as a medical device, you must meet certain regulatory requirements. In this chapter you will get an overview of the legal system as it pertains to medical devices and learn about important topics such as: Medical device regulations Essential requirements you or your product must meet Conformity assessment procedures Harmonized standards Key differences between ...

An introduction to the legal system according to MDR

Last published Courses & Lessons

Interested in joining the MDU?

Coming Soon!

What we have in the pipeline for you that will be coming shortly

Task Course

A new Task Course is in Production and will be launched this summer!

FDA Update

We updated the hole course to the new standarts according to the new FDA publication

New Certificate Design

Check out the new Certificate Design in your profile administration menue!