# 161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-11-06
- Length: 24m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-06-161-iso-14971-and-ich-q9-explained-risk-management-frameworks-in-medical-devices
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/161---ISO-14971-and-ICH-Q9-EXPLAINED-Risk-Management-Frameworks-in-Medical-Devices--Pharma-and-Combination-Products-e2qi72t

## Summary

Host Subhi Saadeh explains the distinct yet complementary roles of ISO 14971 and ICH Q9 in managing risk for combination products, highlighting how ISO 14971 focuses on patient safety through lifecycle management while ICH Q9 addresses broader pharmaceutical quality risks. He details the recent updates in ICH Q9 R1, particularly regarding managing subjectivity and scaling formality, and contrasts the structured, plan-driven approach of device risk management with the more collaborative, problem-driven nature of pharma risk assessments. Saadeh emphasizes critical concepts unique to ISO 14971, such as 'state of the art' for residual risk evaluation and the dual verification of implementation and effectiveness, which are essential for ensuring safety in complex drug-device combinations.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-06-161-iso-14971-and-ich-q9-explained-risk-management-frameworks-in-medical-devices#t=0) Introduction to Risk Management and Frameworks

## Topics

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

## Most relevant to

established companies

## Mentioned

- ISO 14971 (other)
- ICH Q9 (other)
- ICH Q9 R1 (other)
- ISO 13485 (other)
- QMSR (other)
- FMEA (other)
- HACCP (other)
- ASTM Committee E55 (other)
- Combination Products Coalition (other)
- AAMI (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)
- [#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)
- [Risk Management from a Regulatory & Product Development Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-risk-management-from-a-regulatory-product-development-point-of-view) (Global Medical Device Podcast)
- [#362: Managing Risk in Clinical Investigations](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-06-161-iso-14971-and-ich-q9-explained-risk-management-frameworks-in-medical-devices. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.