# [LIVE] Design Controls, Development & Risk for Software as a Medical Device (SaMD)

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-03-26
- Length: 40m
- Episode: 138
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd
- Listen: https://podcast.greenlight.guru/episode/live-design-controls-development-risk-for-software-as-a-medical-device-samd

## Summary

Chris DuPont, CEO of Galen Data, explains how to apply medical device design controls to Software as a Medical Device (SaMD), arguing that software must be treated with the same rigor as mechanical devices. He details the development process, emphasizing the importance of independent verification, early validation through wireframes, and maintaining a living Design History File (DHF) that evolves with agile sprints. DuPont also addresses risk analysis, regulatory pathways, and how Galen Data’s platform helps clients connect devices to the cloud without building custom, expensive compliance infrastructure.

## Chapters

- [1:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd#t=68) Introduction: Tom Rish and Chris DuPont on Galen Data's Mission
- [4:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd#t=241) Treating Software as a Medical Device: Design Inputs and Requirements
- [7:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd#t=430) Verification vs. Validation: Testing Specs vs. User Scenarios
- [10:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd#t=626) Managing Tools, Traceability, and Documentation Cadence
- [13:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd#t=813) Maintaining a Living Design History File (DHF) for Software
- [17:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd#t=1059) Risk Analysis and Software Classification (Class I, II, III)
- [20:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd#t=1242) Software Bill of Materials (S-BOM) and Regulatory Predicates
- [24:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd#t=1487) Galen Data’s Platform: No Custom Software and Cloud Connectivity

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Galen Data (company)
- Tom Rish (other)
- Chris DuPont (other)
- FDA (other)
- ISO 13485 (other)
- IEC 62304 (other)
- AWS (other)
- GitHub (other)
- Jira (other)

## Related episodes from other shows

- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (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)
- [Rapid Prototyping for Medical Devices with Ross Dehmoobed](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-01-11-rapid-prototyping-for-medical-devices-with-ross-dehmoobed) (The Pragmatic Embedded Podcast)
- [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)
- [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)

## 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/2020-03-26-live-design-controls-development-risk-for-software-as-a-medical-device-samd. 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.