Hardware Podcasts

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

Global Medical Device Podcast · 26 Mar 2020 · 40m · Episode 138

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Galen Data
Also
Tom Rish, Chris DuPont, FDA, ISO 13485, IEC 62304, AWS, GitHub, Jira

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