# Past, Present, Future State (and World) of Quality in the Medical Device Industry

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-09-22
- Length: 27m
- Episode: 229
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry
- Listen: https://podcast.greenlight.guru/episode/past-present-future-state-and-world-of-quality-in-the-medical-device-industry

## Summary

Mark Alpert, Director of Quality at Greenlight Guru, discusses the current state of quality in the medical device industry with host Jon Speer. Alpert argues that complexity in quality systems guarantees mistakes and that companies have lost their way by focusing on compliance rather than continuous improvement. He advocates for a 'do versus don't do' mindset during audits to preserve creativity and simplify processes, noting that the industry is currently struggling with the transition to EU MDR and IVDR regulations.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry#t=0) Introduction: Mark Alpert and Greenlight Guru
- [1:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry#t=112) Alpert's 30-Year History in Quality and ISO Standards
- [5:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry#t=303) The 'Hot Mess' of EU MDR and IVDR Transition
- [9:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry#t=587) How Quality Became Tool-Driven and Lost Data Focus
- [12:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry#t=776) The Problem with Over-Documenting Procedures
- [16:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry#t=962) Auditor Bias and the 'Dancing' with Notified Bodies
- [19:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry#t=1141) Compliance vs. Continuous Improvement Mindset
- [22:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry#t=1354) Building Confidence and True Quality Culture

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Mark Alpert (other)
- Jon Speer (other)
- ISO 9000 (other)
- ISO 13485 (other)
- EU MDR (other)
- EU IVDR (other)
- TÜV SÜD (company)
- Kasota Engineering (company)
- Christie Johnson (other)

## Related episodes from other shows

- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)
- [071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols) (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)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (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/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry. 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.