# Tips for Running Better Management Reviews

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-07-19
- Length: 24m
- Episode: 221
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews
- Listen: https://podcast.greenlight.guru/episode/tips-for-running-better-management-reviews

## Summary

Taylor Brown, a senior medical device guru at Greenlight Guru, joins host John Spear to discuss best practices for conducting effective management reviews under ISO 13485 and FDA 21 CFR Part 820. Brown shares a personal anecdote about a failed review where she focused on presentation rather than required inputs like complaints, leading to an audit finding. They emphasize that management reviews should be frequent (twice a year), data-driven, and focused on escalating issues and maintaining the Quality Management System (QMS) rather than just checking boxes.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews#t=0) Introduction and Taylor Brown's Audit Failure Story
- [3:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews#t=226) Regulatory Requirements: ISO 13485 and FDA 21 CFR Part 820
- [5:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews#t=322) Frequency and Purpose: Escalating Issues vs. Checkboxes
- [8:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews#t=525) Defining Measurable Quality Objectives and KPIs
- [12:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews#t=767) Management Review Outputs and Action Plans
- [16:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews#t=970) Data Collection Challenges and Automation
- [18:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews#t=1099) Auditor Access: Notified Bodies vs. FDA
- [21:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews#t=1273) Closing the Loop and Final Tips

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- ISO 13485 (other)
- FDA 21 CFR Part 820 (other)
- Sarah Adams (other)

## Related episodes from other shows

- [198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-23-198-qmsr-explained-iso-13485-compared-and-5-key-things-you-mightve-missed) (Let's Combinate)
- [130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management) (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)
- [168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-25-168-audits-audits-audits-why-they-matter-in-pharma-medical-devices-and-personal) (Let's Combinate)
- [170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-08-170-the-1-secret-to-understanding-iso-13485-youll-wish-you-knew-sooner) (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/2021-07-19-tips-for-running-better-management-reviews. 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.