025 - “The Frying Pan to the Fire” with Edwin Bills

On this episode of the podcast we had Edwin Bills, a Risk Management Expert that was on the committees for ISO14971:2019, ISO TR24971:2020 and AAMI TIR 105:2020. Ed and I discuss Combination Products Risk Management including: His background as an educator Entering Quality after being taught by some of the quality gurus in the 1980's The history of Risk Management in medical devices and what it was like before ISO 14971 Advice for how someone new should look at the risk management documents and standards ISO 14971:2019 Medical devices — Application of risk management to medical devices ISO TR 24971:2020 Guidance On The Application Of ISO 14971 AAMI TIR 105:2020 Risk management guidance for combination products Differences and Similarities between ISO14971 and ICH Q9 Philosophically Constituent vs. Finished Combination Product Risk Management Requirements vs. Guidance in the standards and technical reports Probabilities & Estimation in Risk Management (P1/P2 method) Risk Acceptability and Benefit to Risk Risk Management for Clinical Trials Why he loves Risk Management During his career in medical devices, Ed has held a number of quality and regulatory affairs positions. He is an ASQ Fellow and is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. Ed is also Regulatory Affairs Certified through the Regulatory Affairs Professionals Society and obtained BS and Masters degrees from the University of Cincinnati. Ed served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical device participated in the development of ISO 14971 risk management standard for medical devices. Ed is a current member of the ISO Technical Committee on medical device risk management, which has now completed the 3rd edition of ISO 14971 and the second edition of ISO TR 24971. Ed was also part of the AAMI committee that authored TIR105. In 2016, he co-edited, with Stan Mastrangelo, "Lifecycle Risk Management for Healthcare Products from Research Through Disposal" published by Davis Publishing and available at www.pda.org. Had has also written extensively on medical device and combination product risk management Ed has presented training courses for the American Association of Medical Instrumentation (AAMI) in the area of design controls, risk management, and quality systems, and presented courses at the University of Southern California and the University of Washington in their regulatory affairs graduate programs, and has served as an adjunct professor in the Health Products Risk Management graduate program at Virginia Tech. Currently, he is consulting in the area of medical device quality, regulatory, product liability and risk management. Links: --------------------------------------------------------------- Edwin Bills Linkedin: Link Article Discussed in the Episode - "What Does EN ISO 14971:2019's New Amendment Mean For Harmonisation? " - Link