Hardware Podcasts

#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

Global Medical Device Podcast · 22 Nov 2024 · 58m · Episode 392

What this episode covers

Devon Campbell, a medical device consultant, explains the critical distinctions between verification (did we build the product right?) and validation (did we build the right product?) for early-stage medtech companies. He emphasizes that strong, testable user needs and design inputs are prerequisites for successful V&V, warning that weak requirements lead to validation failures. Campbell advocates for pre-verification testing to refine protocols and manage sample sizes, ensuring that design reviews and traceability are robust before formal regulatory submission.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Also
FDA, ISO 13485, ISO 14971, IEC 62304

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