Risk Management, Innovation and Safety in Medical Devices: Evolving from Compliance to Excellence

Today we discuss the current developments and trends surrounding risk management in the medical device industry. Our guests are Edwin Bills and Shannon Hoste, and they touch upon the challenge of consolidating numerous standards and documents while ensuring the consideration of overall residual risk, encompassing aspects like AI, cybersecurity, and biocompatibility. The conversation explores the need for manufacturers to embrace comprehensive risk management, focusing not only on individual risk analysis but also on evaluating the overall risk of complex systems. We also review ISO 14971, the expansion of guidance documents, and the importance of putting patient safety at the forefront of the risk management process. Join us as we uncover the intricacies and advancements in medical device risk management.Today's episode is hosted by Denise Wagner, Senior Director of Human Factors Engineering and Usability Engineering at Agilis Consulting Group.  Today's guests are Shannon Hoste, President of Agilis by Kymanox, and Edwin Bills, who teaches the AAMI Risk Management course and is involved in the standards development for ISO 14971.About The Factor:
To err is human. That’s where we come in. The Factor is your trusted podcast for the global medical market. We are highlighting various topics and viewpoints within our industry. Our goal is to create dialogue that promotes best practices in creating safer medical products for the end user.  It is brought to you by Agilis by Kymanox, and is produced by Earfluence.