# #335: Accelerating SaMD Development in a Compliant Agile way

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-09-08
- Length: 55m
- Episode: 335
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way
- Listen: https://podcast.greenlight.guru/episode/335-accelerating-samd-development-in-a-compliant-agile-way

## Summary

Zach Markin, CEO, and Weronika Michaluk, Digital Health Principal at HTD Health, discuss accelerating Software as a Medical Device (SaMD) development through a methodology they call 'Compliant Agile.' They explain how HTD uses its 'SaMD Chassis' accelerator to handle common non-differentiating software functions, allowing clients to focus on novel clinical value while maintaining regulatory compliance. The guests detail their selection of Greenlight Guru as their Quality Management System (QMS) because it supports flexible, agile workflows and integrates with tools like Jira, helping them achieve ISO 13485 certification and reduce time-to-market.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way#t=0) Introduction: Zach Markin and Weronika Michaluk of HTD Health
- [5:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way#t=323) HTD Health Background and Mission
- [14:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way#t=840) The SaMD Chassis Accelerator and Common Pitfalls
- [24:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way#t=1454) Compliant Agile Methodology for SaMD
- [33:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way#t=1994) Selecting Greenlight Guru as the QMS
- [45:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way#t=2704) Greenlight Guru ROI and Impact on Timelines
- [49:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-09-08-335-accelerating-samd-development-in-a-compliant-agile-way#t=2996) Future Plans: AI Practice and Growth

## Topics

- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- HTD Health (company)
- Greenlight Guru (company)
- Exos (company)
- Fresh Corner Cafe (company)
- SaMD Chassis (product)
- Jira (tool)
- ISO 13485 (other)

## Related episodes from other shows

- [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)
- [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)
- [Living Documentation and Test Automation with Paul Massey](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-15-living-documentation-and-test-automation-with-paul-massey) (The Pragmatic Embedded Podcast)
- [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)
- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)

## Citing this page

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