The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. This episode is hosted by Denise Wagner, Senior Director, Human Factors Engineering and centers around risk management as it pertains to medical device development. In Part 1, guests Shannon Hoste, President of Agilis Consulting, and Edwin Bills, Risk Management Consultant, discuss the history of the risk analysis landscape and the recent news that FDA is going to incorporate ISO 14971 into it’s Quality Management System Regulation (QMSR). We continue the conversation in Part 2, highlighting the importance of traceability, proper terminology, and the early integration of risk analysis as a design tool.

Watch the Podcast here:

Part 1

Part 2