# Meet a Guru: Tom Rish

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-08-05
- Length: 29m
- Episode: 158
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish
- Listen: https://podcast.greenlight.guru/episode/meet-a-guru-tom-rish

## Summary

Tom Rish, a senior medical device guru at Greenlight Guru, discusses his background in orthopedic implants at Zimmer and his current role helping startups navigate regulatory frameworks. He emphasizes that regulations like FDA 21 CFR 820 and ISO 13485 are simple efficiencies rather than complex burdens, advising companies to 'right-size' their Quality Management Systems (QMS) by focusing only on immediate needs. Rish shares practical advice for one-person teams and early-stage companies, such as writing procedures while performing tasks to ensure they are efficient and avoiding the 'procedure overload' that leads to non-compliance. He highlights the importance of integrating documentation, like risk matrices and user needs, into the daily workflow to prevent last-minute 'non-stop paperwork' crises before submissions or audits.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish#t=0) Introduction: Tom Rish and Greenlight Guru's Guru Edge
- [2:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish#t=137) Tom Rish's Background: Purdue, Zimmer, and Orthopedic Implants
- [6:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish#t=364) The Guru Role: Learning Software, IVDs, and Business Side
- [8:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish#t=514) Regulations as Simple Efficiencies: FDA 21 CFR 820 and ISO 13485
- [10:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish#t=632) One-Man Teams: Helping Surgeons and Sales Reps Commercialize
- [13:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish#t=838) Procedure Overload: Writing and Testing Procedures in Practice
- [17:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish#t=1069) Keys to Customer Success: Focus, Planning, and Right-Sizing QMS
- [20:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish#t=1221) Avoiding Non-Stop Paperwork: Integrating Documentation Daily
- [23:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish#t=1414) Internal Audits: From Checkbox Activity to Robust Trial Runs

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

founders before launch, early-stage companies

## Mentioned

- Greenlight Guru (company)
- Zimmer (company)
- Purdue (other)
- FDA (other)
- ISO 13485 (other)
- Greenlight Guru MDQMS (product)

## Related episodes from other shows

- [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)
- [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)
- [125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-28-125-unpacking-the-quality-management-system-regulation-qmsr-final-rule-with-subh) (Let's Combinate)
- [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)
- [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)

## 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/2020-08-05-meet-a-guru-tom-rish. 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.