# S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements

- Show: [Being an Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer)
- Published: 2024-07-19
- Length: 51m
- Episode: 29
- Page: https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements
- Listen: https://teampipeline.us/steve-gompertz-medical-device-qc/

## Summary

Steve Gompertz, a partner at QRx Partners with prior leadership roles at Medtronic, Boston Scientific, St. Jude Medical, and Pelican Biothermal, explains how to build scalable quality management systems for medical device companies. He details the evolution of regulatory frameworks, noting the shift toward stricter EU standards and the integration of AI and cybersecurity into device compliance. Gompertz emphasizes tailoring quality systems to company size, using a case study of a client who reduced FDA findings from dozens to zero by implementing a holistic, process-connected system rather than a checklist approach. He also advocates for concurrent engineering and cross-functional teams to accelerate development while maintaining rigorous safety standards.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements#t=0) Introduction: Steve Gompertz and QRx Partners
- [2:22](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements#t=142) Gompertz's Career Path and Engineering Background
- [6:08](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements#t=368) Evolution of Global Medical Device Regulations
- [11:58](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements#t=718) Balancing Innovation with Quality Control
- [14:55](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements#t=895) Tailoring Quality Systems for Small vs. Large Companies
- [18:01](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements#t=1081) Common Pitfalls: Checklist vs. System Thinking
- [21:50](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements#t=1310) Core Components and Evolution of a Quality System
- [26:25](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements#t=1585) Emerging Trends: AI, Machine Learning, and Cybersecurity
- [36:26](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements#t=2186) Case Study: Revamping a Client's Quality System
- [44:57](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements#t=2697) Accelerating Engineering via Concurrent Engineering

## 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)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Security & privacy](https://hardwarepodcasts.com/topic/security-and-privacy)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

early-stage companies, companies scaling up, large enterprises

## Mentioned

- QRx Partners (company)
- Medtronic (company)
- Boston Scientific (company)
- St. Jude Medical (company)
- Pelican Biothermal (company)
- FDA (other)
- ISO 13485 (other)
- Pipeline Design & Engineering (company)

## Related episodes from other shows

- [Past, Present, Future State (and World) of Quality in the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry) (Global Medical Device Podcast)
- [#379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-15-379-meet-the-guru-building-quality-management-in-early-stage-medical-device-comp) (Global Medical Device Podcast)
- [#440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory) (Global Medical Device Podcast)
- [#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-07-390-building-a-non-bs-qms-4-core-principles-for-medtech-success-with-ashkon-raso) (Global Medical Device Podcast)
- [Meet a Guru: Karen Schuyler](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler) (Global Medical Device Podcast)

## Citing this page

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