Hardware Podcasts

#371: Achieving ISO 13485 Certification

Global Medical Device Podcast · 28 May 2024 · 45m · Episode 371

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
HTD Health
Tools
Greenlight Guru, Jira
Also
ISO 13485, ISO 14971, FDA

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