Tony Cobar is the Director, R&D Quality Engineering for Abbott Laboratories - Ventures Division, with over 25 years of experience in the medical device field. Originally from Guatemala, he came to the United States at the age of 7. He grew up in East Los Angeles where he earned his Biomedical Engineering B.S. from the University of Southern California. Now living in the Bay Area, Tony joined Abbott Ventures in August 2015, and has held several roles of increasing responsibility. Tony has worked in various engineering and development roles for Hanson Medical (Robotic Catheters), Solta Medical, Coapt Systems (Bio-absorbable devices), Mattel, Inc, (Toys), and Royce Medical (Orthopedic).

Abstract

Design Controls for Medical Devices - FDA 21CFR 820.30

Healthcare is a Multi-Billion dollar industry that is highly regulated to ensure that products and devices that are sold are safe and effective. There are many regulations and standards that govern these products and devices. However, no matter what technology you are in or what personalized healthcare device you will design, Design Controls is fundamental for your success. In this session you will learn how Design Controls is critical for today's personalized healthcare field.