The journey to bringing a medical device to market starts and ends with managing risk, with a healthy dose in the middle as well. From early development days assessing technical execution risks to planning mitigations for what may happen during clinical use, foreseeable mis-use, future label expansions and the full product lifecycle, a successful device program will take all these into account to bring a product that's safe and effective to market. This talk will cover the approach to of risk identification, analysis, mitigation and monitoring required of engineers and other technical staff for medical device design with examples of success and failure. Speaker(s): Mike Hess Agenda: Agenda 6:00 - 6:10pm EMBS-SCV and co-hosts introduction 6:10 - 6:45pm Speaker presentation 6:45 - 7:00pm Q & A Virtual: https://events.vtools.ieee.org/m/377033