# 127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-03-13
- Length: 48m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/127---BIG-Risk-Management-Changes-in-QMSR--Risk-Acceptability--Risk-Policy--Explaining-vs--Justifying-Risk-Decisions-with-Naveen-Aggarwal-e2gt0sn

## Summary

Naveen Aggarwal, founder of Creative Analytic Solutions, explains that the QMSR final rule does not mandate ISO 14971 but requires risk management to be integrated into ISO 13485 quality systems, shifting FDA inspection focus from procedural compliance to risk-based decision-making. He highlights that small and mid-size companies face significant costs to transition, while large firms must overcome the challenge of linking risk outputs to design inputs and post-market data. Aggarwal advises against standalone risk policies, suggesting instead that companies integrate risk acceptability criteria into their existing quality policies and use clear, binary (red/green) risk matrices rather than ambiguous yellow zones.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin#t=0) Introduction: Naveen Aggarwal and Creative Analytic Solutions
- [2:28](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin#t=148) QMSR and ISO 14971: Mandatory vs. Harmonized Requirements
- [8:17](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin#t=497) QMSR Impact on Risk Management and FDA Inspections
- [14:41](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin#t=881) FDA Warning Letters and Post-Market Risk Calculation Errors
- [24:54](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin#t=1494) Integrating Risk Acceptability into Quality Policy
- [31:41](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin#t=1901) Risk Control: As Far As Possible (AFAP) and Benefit-Risk Analysis
- [40:31](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-13-127-big-risk-management-changes-in-qmsr-risk-acceptability-risk-policy-explainin#t=2431) Risk Acceptability Charts: Red/Green vs. Yellow Zones

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Creative Analytic Solutions (company)
- ISO 13485 (other)
- ISO 14971 (other)
- QMSR (other)
- FDA (company)
- JNJ (company)

## Related episodes from other shows

- [#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-21-474-behind-the-qmsr-audits-the-top-5-fda-citations-risk-management-pitfalls) (Global Medical Device Podcast)
- [#438: QMSR Mythbusters Episode](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-22-438-qmsr-mythbusters-episode) (Global Medical Device Podcast)
- [QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices) (Global Medical Device Podcast)
- [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)
- [How does EU MDR impact your Quality Management System?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-22-how-does-eu-mdr-impact-your-quality-management-system) (Global Medical Device Podcast)

## Citing this page

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