# Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-02-10
- Length: 40m
- Episode: 179
- Page: 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
- Listen: https://podcast.greenlight.guru/episode/inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view

## Summary

Ed Bills, a risk management consultant and technical committee member for ISO 14971:2019 and ISO TR 24971:2020, joins host Jon Speer to explain the nuances of the updated international medical device risk management standards. They discuss the separation of guidance from requirements, the critical role of post-market surveillance in Clause 10, and the regulatory landscape involving the EU MDR and IVDR. Bills emphasizes that risk management is a product safety standard distinct from business or project risk, and advises companies to read the full rationale and technical report to avoid common misinterpretations.

## Chapters

- [0:21](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#t=21) Introduction to ISO 14971:2019 and ISO TR 24971:2020
- [9:42](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#t=582) The Development Process and Global Consensus
- [17:11](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#t=1031) Clarifying Z Annexes and EU MDR/IVDR Harmonization
- [23:04](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#t=1384) Clause 10: Post-Market Surveillance and Lifecycle Updates
- [33:14](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#t=1994) Qualitative vs. Quantitative Risk Assessment and Severity
- [37:49](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#t=2269) Key Advice: Reading the Rationale and Full Standards

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

established companies

## Mentioned

- ISO 14971:2019 (other)
- ISO TR 24971:2020 (other)
- Greenlight Guru (company)
- EU MDR (other)
- EU IVDR (other)
- FDA (company)
- BSI (company)
- IEC 60601 (other)
- ISO 13485 (other)
- GHTF (company)

## Related episodes from other shows

- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (Let's Combinate)
- [161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products](https://hardwarepodcasts.com/podcast/lets-combinate/2024-11-06-161-iso-14971-and-ich-q9-explained-risk-management-frameworks-in-medical-devices) (Let's Combinate)
- [127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin) (Let's Combinate)
- [236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-29-236-ich-q9-quality-risk-management-qrm-iso-14971-differences) (Let's Combinate)
- [098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-16-098-medtech-vs-aerospace-risk-management-afap-vs-alarp-alara-quantifying-benefit) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to 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. 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 Global Medical Device Podcast.