Hardware Podcasts

#431: Meet Alex Naber: Insider Insights on Quality Systems, Design Quality, and MedTech's Patient-First Ethos

Global Medical Device Podcast · 3 Nov 2025 · 26m · Episode 431

What this episode covers

Alex Naber, a medical device consultant at Greenlight Guru, discusses his career path from bioengineering to design quality and post-market management at Zimmer Biomet. He explains how Greenlight Guru's eQMS and EDC solutions eliminate the pain points of fragmented, spreadsheet-based design controls by building true, linked traceability directly into the system. Naber also highlights the value of pre-built QMS templates that accelerate implementation for small-to-midsize companies, avoiding the 'bloated' procedures typical of large corporations. Finally, he addresses the upcoming QMSR transition, reassuring listeners that compliance is manageable for those already adhering to ISO 13485.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, Zimmer Biomet, High Ridge Medical
Products
Tether
Also
ISO 13485, QMSR, FDA

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