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.
We’ve done most of the work for you. Choose from more than 150 templates that cover all your technical documentation needs.
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.
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.
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 course 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 t ...