Hardware Podcasts

Meet a Guru: Maryann Mitchell

Global Medical Device Podcast · 2 Sept 2021 · 15m · Episode 226

What this episode covers

Maryann Mitchell, a Solutions Engineer at Greenlight Guru, discusses her background in quality systems and her role helping medical device companies evaluate the Greenlight Guru Medical Device Success Platform (MDSP). She highlights the platform's ability to streamline design control and risk matrices, which helps companies achieve audit readiness and faster ISO 13485 compliance. Mitchell also addresses current industry challenges, specifically the complexities of EU MDR submissions and the potential transition of FDA inspections toward ISO 13485 standards.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Products
Greenlight Guru Medical Device Success Platform, ETQ
Also
ISO 13485, FDA, EU MDR, EU IVDR

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