# Navigating the Medical Device Single Audit Program (MDSAP)

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-04-13
- Length: 40m
- Episode: 254
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-13-navigating-the-medical-device-single-audit-program-mdsap
- Listen: https://podcast.greenlight.guru/episode/navigating-the-medical-device-single-audit-program-mdsap

## Summary

Danny Kroo, a medical device consultant and sub-contract lead auditor for registrars like BSI, joins Jon Speer and Etienne Nichols of Greenlight Guru to explain the Medical Device Single Audit Program (MDSAP). Kroo details how MDSAP consolidates regulatory audits for the US, Canada, Japan, Brazil, and Australia, noting that while it simplifies global market access, it has raised costs and barriers for small companies. He emphasizes that the audit is highly prescriptive, relying on a 231-page FDA 'Audit Approach' document, and warns that companies with immature quality systems often struggle with specific requirements like change control and internal auditor qualifications.

## Chapters

- [2:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-13-navigating-the-medical-device-single-audit-program-mdsap#t=152) Introduction to MDSAP and its Origins
- [4:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-13-navigating-the-medical-device-single-audit-program-mdsap#t=294) Impact on Small Companies and Market Access
- [11:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-13-navigating-the-medical-device-single-audit-program-mdsap#t=689) MDSAP vs. ISO 13485 and Audit Prescriptiveness
- [18:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-13-navigating-the-medical-device-single-audit-program-mdsap#t=1139) Common Pitfalls and Mock Audits
- [22:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-13-navigating-the-medical-device-single-audit-program-mdsap#t=1332) FDA Inspection Trends and EU MDR Impact
- [25:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-13-navigating-the-medical-device-single-audit-program-mdsap#t=1546) Future of FDA Regulation and Quality Systems
- [30:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-13-navigating-the-medical-device-single-audit-program-mdsap#t=1816) The Role of eQMS and Tribal Knowledge

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- BSI (company)
- Health Canada (company)
- FDA (company)
- ISO 13485 (other)
- EU MDR (other)
- DocuSys (company)

## Related episodes from other shows

- [215 - Why Aren’t Technical People Leading Drug-Device Audits?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-26-215-why-arent-technical-people-leading-drug-device-audits) (Let's Combinate)
- [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)
- [130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management) (Let's Combinate)
- [168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-25-168-audits-audits-audits-why-they-matter-in-pharma-medical-devices-and-personal) (Let's Combinate)
- [003 - “Standard Understanding” with Mark Swanson](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-20-003-standard-understanding-with-mark-swanson) (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/2022-04-13-navigating-the-medical-device-single-audit-program-mdsap. 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.