# #325 The Role of dFMEAs in Risk Management for Medical Devices

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-06-30
- Length: 36m
- Episode: 325
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices
- Listen: https://podcast.greenlight.guru/episode/325-the-role-of-dfmeas-in-risk-management-for-medical-devices

## Summary

Wade Schroeder, a medical device expert at Greenlight Guru, explains how dFMEA and ISO 14971 work together to manage risk in medical device design. He argues that while dFMEA provides a useful bottom-up technical view, ISO 14971 offers a necessary top-down, patient-focused strategy that maps directly to FDA expectations. Schroeder highlights Greenlight Guru’s software as a tool that integrates risk management with design controls, reducing the complexity of maintaining separate systems. The discussion emphasizes using tools like fault tree analysis and fishbone diagrams to ensure comprehensive safety without compromising regulatory compliance.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices#t=0) Introduction: Wade Schroeder and Greenlight Guru
- [3:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices#t=225) ISO 14971 as a Top-Down Patient Safety Strategy
- [7:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices#t=426) Mitigation Hierarchy: Inherent Safety vs. IFU
- [13:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices#t=825) Comprehensive Risk Analysis with Fishbone and Fault Tree
- [22:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices#t=1369) dFMEA as a Bottom-Up Tactical Tool
- [28:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices#t=1715) Mapping dFMEA to ISO 14971 for FDA Review
- [29:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices#t=1790) Greenlight Guru Software and Risk Intelligence

## 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)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- ISO 14971 (other)
- dFMEA (other)
- FDA (other)
- Greenlight Guru Risk Intelligence (product)

## Related episodes from other shows

- [095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-26-095-how-fmea-fits-into-iso14971-probabilities-severity-of-harm-rpns-pfmeas-and-m) (Let's Combinate)
- [202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin](https://hardwarepodcasts.com/podcast/lets-combinate/2025-08-20-202-becoming-an-expert-in-the-work-nobody-wants-to-do-design-risk-and-the-messy) (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)
- [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)
- [258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin](https://hardwarepodcasts.com/podcast/lets-combinate/2026-10-12-258-combination-product-quality-human-factors-cdmo-scorecards-iso-14971-vs-ich-q) (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/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-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 Global Medical Device Podcast.