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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-03-23
- Length: 1h 31m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/025---The-Frying-Pan-to-the-Fire-with-Edwin-Bills-e1g2ued

## Summary

Edwin Bills, a Risk Management Expert and former committee member for ISO 14971, ISO TR 24971, and AAMI TIR 105, explains the evolution of risk management standards in medical devices and combination products. He details the philosophical differences between ISO 14971 and ICH Q9, emphasizing that risk management must focus on patient safety rather than just regulatory compliance. Bills advises engineers to use qualitative methods early in development and highlights the importance of analyzing interactions between drug and device constituents in combination products. He also discusses the expanded requirements for post-market surveillance in the 2019 standard and the upcoming harmonization of ISO 14971 in Europe.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=0) Introduction: Edwin Bills and his background in quality and risk management
- [4:31](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=271) Ed's educational background and training under quality gurus like Dr. Joseph Duran
- [13:27](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=807) History of risk management standards from EN 1441 to ISO 14971
- [25:42](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=1542) Normative requirements, annexes, and the 2019 amendment for European harmonization
- [37:41](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=2261) Transition from prescriptive standards (UL 544) to risk-based approaches
- [40:16](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=2416) Philosophical comparison of ISO 14971 and ICH Q9 for combination products
- [48:02](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=2882) Constituent vs. finished combination product risk assessment and TIR 105
- [52:23](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=3143) Probabilities, P1/P2 methods, and qualitative vs. quantitative risk estimation
- [57:13](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=3433) Risk acceptability, benefit-to-risk, and state of the art
- [1:01:39](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=3699) Post-market risk management activities and clinical trial integration
- [1:06:47](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=4007) Advice for newcomers on navigating TIR 105, TR 48, and regulatory expectations
- [1:16:02](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills#t=4562) Bills' passion for risk management and future trends including cybersecurity

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

established companies

## Mentioned

- ISO 14971 (other)
- ISO TR 24971 (other)
- AAMI TIR 105 (other)
- ICH Q9 (other)
- EN 1441 (other)
- IEC 60601 (other)
- UL 544 (other)
- ISO 14155 (other)
- TR 48 (other)
- ISO 31000 (other)

## Related episodes from other shows

- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)
- [#422: ISO 14971 and the Road to Risk Management with Edwin Bills](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills) (Global Medical Device Podcast)
- [#445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech) (Global Medical Device Podcast)
- [#325 The Role of dFMEAs in Risk Management for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices) (Global Medical Device Podcast)
- [#418: Biocompatibility Brief - What Medical Device Companies Need to Know](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-08-04-418-biocompatibility-brief-what-medical-device-companies-need-to-know) (Global Medical Device Podcast)

## Citing this page

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