Hardware Podcasts

#417: Evaluating EQMS: A Crucial Step for Medtech Success

Global Medical Device Podcast · 28 Jul 2025 · 43m · Episode 417

What this episode covers

Andy Rogantino, an account executive at Greenlight Guru, joins host Etienne Nichols to discuss the strategic evaluation and implementation of Electronic Quality Management Systems (EQMS) for medical device companies. They argue that teams should integrate an EQMS early in the product lifecycle rather than waiting for regulatory crises, emphasizing the need to involve cross-functional stakeholders including product development, regulatory, IT, and leadership. The conversation details key evaluation criteria, such as ensuring the software is purpose-built for MedTech compliance with standards like ISO 13485 and 21 CFR Part 820, while avoiding overly customizable generic platforms that hinder adoption.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, Abies, Signal Therapeutics, Decro, 2nd Nature, Moderna, Hulu, Activision
Products
Linskin Golf, Call of Duty

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