Hardware Podcasts

S1E12 Simplifying Quality Management | Jon Speer

Being an Engineer · 5 Jun 2020 · 37m · Episode 12

What this episode covers

Jon Speer, founder of Greenlight Guru, explains how his frustration with managing medical device quality via Excel spreadsheets led to the creation of a dedicated QMS software platform. He details the transition from chemical engineering to medical device systems, highlighting the specific pain points of manual data merging and the high validation burden for electronic records. The episode covers Greenlight Guru’s development, its focus on design controls and traceability matrices, and the regulatory challenges of FDA submissions and ISO 13485 certification for startups.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Tools
CAD
Also
FDA, ISO 13485, Global Medical Device Podcast

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