Clinical Science for Medical Devices: Clinical Trials & Studies Seminar
This seminar will help medical device entrepreneurs better understand the need and value of clinical studies, whether for FDA approval or for a market launch. Clinical studies can be long, expensive, and risky—but if done well, they can also bring significant reward.
In this webinar, you’ll answer:
• Do I need a clinical study to get FDA approval to market my device?
• If yes, what options do I have, what regulatory requirements apply, and what are the costs and risks?
• If not, what other reasons might still favor a clinical study, and how can I sponsor one?
Your Guide: Jim Gustafson
Jim is a retired (but still active!) medical device executive. He has more than 30 years of experience in Class II and III medical device clinical studies and regulatory strategy for new medical devices. He has managed more than 12 IDE and post-approval medical device clinical trials that together enrolled and followed more than 3,000 patients at more than 100 hospitals and clinics on three continents. He has received more than 75 510(k), PMA, PMA supplement, IDE, and HDE approvals from the FDA. He has had more than 15 face-to-face meetings with the FDA, made 3 presentations to the FDA Advisory Panels, and cleared 3 FDA Warning Letters. He helped his company win the 2010 Baldridge National Quality Award.
