Speed your medical devices to market by attending this complimentary webinar which takes you step by step through the process of submitting your medical devices for approval by the FDA. This webinar will provide an overview of the complex process and provide an understanding of the critical steps.
What participants will learn:
- Classifying your device
- Identifying the correct premarket submission
- Preparing the premarket submission
- Submitting to the FDA
- Establishing a registration and device listing
Michael Lynch, Managing Consultant, Intertek
Since 1981 Mike Lynch has worked almost exclusively in the Medical Device industry. Mike’s career started as a design and manufacturing engineer responsible for high volume disposable products. He progressed to leadership positions in R&D, product development, manufacturing, and marketing with a number of medical device companies spanning a diverse spectrum of products including orthopaedic and ophthalmic implants, electromechanical capital equipment, and single patient use diagnostic tests. Throughout Mike’s career he has led the implementation of product development, design control, and quality management systems.
Heather Thompson, Moderator, Medical Design & Outsourcing
Heather Thompson is senior editor for Medical Design & Outsourcing magazine. She has spent over a decade covering medical and diagnostic technologies for business publications, and is the former editor-in-chief of MD&DI.