Hardware Podcasts

Meet a Guru: Karen Schuyler

Global Medical Device Podcast · 8 Mar 2021 · 25m · Episode 185

What this episode covers

Karen Schuyler, a Medical Device Guru at Greenlight Guru, discusses her 15-year career spanning product engineering at Gore, startup scaling, and quality strategy at large medical device companies. She highlights the industry's shift toward collaborative regulatory approaches and the challenges of adapting to frequent standard updates like ISO 13485 and EU MDR. Schuyler explains how Greenlight Guru’s software solves the inefficiency of manual traceability by automating linkages between design controls, risk management, and documentation, preventing the 'painting yourself into a corner' scenarios common in legacy systems.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, Gore, Product
Also
ISO 13485, EU MDR

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