Hardware Podcasts

#335: Accelerating SaMD Development in a Compliant Agile way

Global Medical Device Podcast · 8 Sept 2023 · 55m · Episode 335

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
HTD Health, Greenlight Guru, Exos, Fresh Corner Cafe
Products
SaMD Chassis
Tools
Jira
Also
ISO 13485

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