# #371: Achieving ISO 13485 Certification

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-05-28
- Length: 45m
- Episode: 371
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-28-371-achieving-iso-13485-certification
- Listen: https://podcast.greenlight.guru/episode/371-achieving-iso-13485-certification

## Summary

Weronika Michaluk and Zach Markin from HTD Health discuss their journey to achieving ISO 13485 certification, emphasizing the critical role of gap analysis and the use of Greenlight Guru’s eQMS software to manage traceability and compliance. They explain how HTD Health implemented a 'compliant agile' approach, writing SOPs that reflected their actual software development processes rather than idealized templates, which helped them pass their audit with an impressed auditor. The conversation highlights the importance of internal expertise, proper tooling for risk management and CAPA, and maintaining continuous improvement in the medical device software space.

## Outline

1. Introduction: HTD Health and the ISO 13485 Journey
2. Motivations for Certification: Safety, Trust, and Efficiency
3. Preparation: Gap Analysis and Implementing Greenlight Guru
4. Audit Success: Traceability, CAPA, and Risk Management
5. Challenges: Implementing CAPA and Internal Audits
6. Advice: Gap Analysis, Documentation, and Tooling
7. Product Evolution and Surface Area
8. SOPs and Compliant Agile Methodology
9. Future Goals: Continuous Improvement and Best in World Thinking

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

early-stage companies

## Mentioned

- HTD Health (company)
- Greenlight Guru (tool)
- ISO 13485 (other)
- ISO 14971 (other)
- Jira (tool)
- FDA (other)

## 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)
- [Weronika Michaluk on Medical Devices development](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-09-04-weronika-michaluk-on-medical-devices-development) (The Pragmatic Embedded Podcast)
- [170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-08-170-the-1-secret-to-understanding-iso-13485-youll-wish-you-knew-sooner) (Let's Combinate)
- [188 – Certified Quality Auditor(CQA) and Audits in the Future](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-14-188-certified-quality-auditor-cqa-and-audits-in-the-future) (Let's Combinate)
- [134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-01-134-iso62304-software-development-process-samd-closed-loop-systems-complexities) (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/2024-05-28-371-achieving-iso-13485-certification. 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.