Hardware Podcasts

Implementing an eQMS after Switching from Paper

Global Medical Device Podcast · 2 Feb 2023 · 31m · Episode 304

What this episode covers

Kendyl Williams, a Medical Device Guru at Greenlight Guru, details her experience transitioning a medical device company from a paper-based Quality Management System (QMS) to the Greenlight Guru eQMS platform. She describes the logistical failures of the paper system, such as 'document signing parties' and lost binders, and explains how the team validated the new software by locking themselves in a coffee shop to test workflows. Williams highlights the importance of using the sandbox environment to learn the system without risking live data and emphasizes the need for intentional setup regarding document nomenclature and attributes to ensure traceability between risk and design controls.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Also
ISO 13485, ISO 14971, David Dram, Connor, Nick Tipman, It's Always Sunny in Philadelphia

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