A Primer on FDA Requirements for Medical Systems

Agenda-
6:00-7:00PM - Networking and Snacks
7:00-7:20PM - Overview and Group Discussion
7:20-8:10PM - A Primer on FDA Requirements for Medical Systems
8:10-8:20PM - Break
8:20-9:00PM - Tips for Entrepreneurs Driving the Digital Health Revolution

Topic 1: A Primer on FDA Requirements for Medical Systems

Presentation will include:

What is a Medical Device? Some Examples of Medical Devices vs. Non-Medical Devices Regulatory Requirements for Medical Devices: Overview of Premarket Notification, Premarket Approval Regulatory Requirements for Medical Device Manufacturers: Overview of Registration, Listing, Good Manufacturing Practices and Other Regulatory Requirements Focus on Software as a Medical Device or Part of a Medical Device: Specific Concerns Speaker: Eric Anderson
Eric Anderson is a Consumer Safety Officer in the FDA's San Francisco District. He supervises FDA Investigators who perform inspections and investigations of regulated companies, including medical device companies.

Prior to becoming a supervisor in April 2004 Eric worked as an Investigator in both Los Angeles District and San Francisco District for fourteen years, performing inspections and investigations of many FDA-regulated companies and institutions in the fields of medical devices, food manufacturing, blood banking, and drug residues in cattle. Between 1994 and 2004 he specialized in medical devices, becoming certified at Level II in medical device inspections (an internal FDA designation) in 1999. During that same time he conducted numerous inspections of foreign medical device manufacturers in both Europe and Asia.

Eric Anderson holds a Bachelors of Arts in Physical Sciences from the University of California at Berkeley.

Topic 2: Tips for Entrepreneurs Driving the Digital Health Revolution

This discussion will focus on digital health phenomenon and the role of the entrepreneur in the journey, including the idea behind founding RockHealth.

Speaker: Halle Tecco
Halle Tecco is a Founder & CEO of RockHealth - the first startup accelerator devoted exclusively to health companies. Tecco recognized the need and potential for startups in the digital health space while working at Apple's App Store covering the health and medical vertical. Previously, she founded Yoga Bear, a national nonprofit that provides yoga to the cancer community in hospitals and at over 200 partner studios.

Tecco has been named as one of “12 Entrepreneurs Reinventing Healthcare” by CNN, one of “15 Women to Watch in Tech” by Inc. Magazine, and was a L’Oreal “Woman of Worth” Honoree. Tecco has written for Harvard Business School Publishing, Stanford Social Innovation Review, Glamour.com and ForbesWoman. She has a Bachelor of Science degree from Case Western Reserve University and a Master of Business Administration from Harvard Business School.