Hardware Podcasts

V&V Activities from a Verification Engineer POV - How Hard Could It Be?

Global Medical Device Podcast · 15 Mar 2023 · 32m · Episode 310

What this episode covers

Niki Price, a Medical Device Guru at Greenlight Guru with 15 years of experience, explains the critical distinction between design verification (testing design inputs) and design validation (testing user needs). She details the verification engineer's workflow, including managing complex trace matrices, writing protocols, and handling anomalies, while contrasting the inefficiencies of manual Excel-based systems with the automation of Greenlight Guru. Price highlights common pitfalls such as ambiguous requirements, version control errors, and the emotional toll of field failures, advocating for rigorous checks and balances in the design assurance process.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Tools
Excel
Also
Niki Price, Etienne Nichols, FDA, ISO 13485

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