# #378: Who Owns the Design Controls Process?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-08-08
- Length: 34m
- Episode: 378
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-08-378-who-owns-the-design-controls-process
- Listen: https://podcast.greenlight.guru/episode/378-who-owns-the-design-controls-process

## Summary

Laura Maher, a design assurance professional at Greenlight Guru, discusses the critical role of ownership in medical device design controls with host Etienne Nichols. They explore the concept of a 'design assurance professional' who bridges the gap between product development, quality, and regulatory teams to create clear, audit-ready documentation. The conversation covers the importance of understanding user needs, the collaborative nature of risk management, and the distinction between technical design reviews and broader stage reviews.

## Outline

1. Introduction and Poll Results on Documentation Ownership
2. The Role of the Design Assurance Professional
3. Audience and Purpose of Design Documentation
4. Collaboration in Risk Management and Traceability
5. Design Reviews vs. Stage Reviews
6. Essential Skills and Final Advice

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

large enterprises

## Mentioned

- Rook Quality Systems (company)
- Medtronic (company)
- Stryker (company)
- ISO 13485 (other)
- QMSR (other)

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- [014B - "The Second P: Process" with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014b-the-second-p-process-with-larry-mager) (Let's Combinate)
- [002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager) (Let's Combinate)
- [157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific) (Let's Combinate)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)

## Citing this page

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