A brilliant design for a medical device means nothing if you can’t get it past the scrutiny of a regulatory body (e.g, FDA). This full day workshop will provide insights into the basics of medical device regulations to help you understand activities needed to bring a medical device to market and to successfully navigate the ever-increasing challenges of this exciting field.
Workshop sessions will include an introduction to US regulations and working with the FDA, conducting clinical studies, design of quality systems, submission pathways, as well as advertising and promotion requirements, and working with FDA. All sessions will be conducted by some of the most respected experts in the field.
This workshop will provide critical knowledge for anyone new to the medical device industry, planning a career in medical devices or looking for a way to refresh and enchance their regulatory knowledge.