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.
We’ve done most of the work for you. Choose from more than 150 templates that cover all your technical documentation needs.
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.
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.
We can help you avoid the costly re-audit process, to save money and protect your product launch timeline.
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.
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.
Have a look at one of our training videos to convince yourself of the quality of MDU
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 ...
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.
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 ...
What we have in the pipeline for you that will be coming shortly
A new Task Course is in Production and will be launched this summer!
We updated the hole course to the new standarts according to the new FDA publication
Check out the new Certificate Design in your profile administration menue!