Monday, September 12, 2022 1:00pm to 2:00pm
About this Event
This seminar will give an introduction to the FDA and the basics of medical device regulation for academic entrepreneurs.
Topics Discussed:
- Who are the FDA? (people and organization)
- What do they do? (how a file is reviewed to get your device on the market)
- How to classify your device and what that means for your regulatory journey
- Overview of the different paths to market through FDA depending on your device classification
Michael Nilo is a biomedical engineer with 13+ years in the medical device industry, working at the FDA, for industry and as a consultant. He has hands-on familiarity with most functions and departments of a successful medical device company, and has provided consulting advice for verification and validation testing, quality systems, and regulatory submissions for different classes of medical devices. As a consultant, he has authored and submitted applications to FDA for Class II and III medical devices, and has extensive experience with Q-submissions, clinical trial development for medical devices, quality system regulations, and all manner of FDA interactions.
Register in-advance for this online event.
The SHRS Innovation Seminar Series is an opportunity for our community to gather together to learn about commercialization as an impactful rehabilitation research translation strategy. The open discussions included during each seminar are a networking opportunity and facilitate interdisciplinary collaboration on specific commercialization projects. The series is co-sponsored by the School of Health and Rehabilitation Sciences and the Office of Innovation and Entrepreneurship’s Innovation Institute.
Please let us know if you require an accommodation in order to participate in this event. Accommodations may include live captioning, ASL interpreters, and/or captioned media and accessible documents from recorded events. At least 5 days in advance is recommended.
Register for Zoom information.