# What is Regulatory Due Diligence for Medical Devices?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-06-24
- Length: 41m
- Episode: 152
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-06-24-what-is-regulatory-due-diligence-for-medical-devices
- Listen: https://podcast.greenlight.guru/episode/what-is-regulatory-due-diligence-for-medical-devices

## Summary

Mike Drues of Vascular Sciences joins host Jon Speer to define regulatory due diligence as the process of analyzing existing devices and technologies to inform business, regulatory, and engineering decisions before investing resources. Drues distinguishes this from regulatory strategy and pathway, explaining how due diligence applies to both existing products for change management and novel devices by decoupling new technologies into known components. The conversation highlights the importance of integrating regulatory and quality due diligence into the total product lifecycle rather than treating them as static, one-time events.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-06-24-what-is-regulatory-due-diligence-for-medical-devices#t=0) Introduction: Regulatory Due Diligence Defined
- [1:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-06-24-what-is-regulatory-due-diligence-for-medical-devices#t=116) Scope of Due Diligence: Existing vs. Novel Devices
- [7:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-06-24-what-is-regulatory-due-diligence-for-medical-devices#t=472) Distinguishing Due Diligence, Strategy, and Pathway
- [11:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-06-24-what-is-regulatory-due-diligence-for-medical-devices#t=662) Applying Due Diligence to Existing Products and Lifecycle Updates
- [16:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-06-24-what-is-regulatory-due-diligence-for-medical-devices#t=972) The Problem with Static Quality Systems and Reactive Culture
- [21:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-06-24-what-is-regulatory-due-diligence-for-medical-devices#t=1270) Decoupling Technologies for Novel Devices and FDA Submissions
- [26:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-06-24-what-is-regulatory-due-diligence-for-medical-devices#t=1595) Cross-Functional Collaboration and Breaking Down Silos
- [30:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-06-24-what-is-regulatory-due-diligence-for-medical-devices#t=1816) Defining Quality Due Diligence and Avoiding Copy-Paste QMS

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Greenlight Guru (company)
- FDA (other)
- 510 K (other)
- De Novo (other)
- PMA (other)

## Related episodes from other shows

- [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)
- [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)
- [058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban) (Let's Combinate)
- [172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg) (Let's Combinate)
- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (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/2020-06-24-what-is-regulatory-due-diligence-for-medical-devices. 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.