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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-03-15
- Length: 32m
- Episode: 310
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be
- Listen: https://podcast.greenlight.guru/episode/vv-activities-from-a-verification-engineer-pov-how-hard-could-it-be

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be#t=0) Introduction and Sponsor Read
- [2:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be#t=151) Niki Price's Background: From Medical Illustration to Verification Engineering
- [4:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be#t=285) The Verification Engineer Workflow: Requirements, Protocols, and Trace Matrices
- [12:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be#t=752) Defining Verification vs. Validation and Managing Test Protocols
- [17:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be#t=1038) Handling Anomalies, Root Cause Analysis, and Reporting
- [22:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be#t=1323) The Design Assurance Professional Role and Career Path
- [25:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be#t=1501) Challenges: Field Failures, Emotional Toll, and Checks and Balances
- [28:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be#t=1686) Industry Pitfalls: Interchanging Verification and Validation

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [EDA & CAD tools](https://hardwarepodcasts.com/topic/eda-and-cad-tools)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Niki Price (other)
- Etienne Nichols (other)
- Excel (tool)
- FDA (other)
- ISO 13485 (other)

## Related episodes from other shows

- [157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific) (Let's Combinate)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [S1E17 Precise Speech, Customer Success, & General Engineering Love | Jesseca Lyons](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-26-s1e17-precise-speech-customer-success-general-engineering-love-jesseca-lyons) (Being an Engineer)
- [Dakota Welker | User Needs, Design Inputs, Verification & Validation](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation) (Being an Engineer)
- [E94 Requirements Engineering, part 1: Fundamentals](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-04-15-e94-requirements-engineering-part-1-fundamentals) (The Pragmatic Embedded Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-15-v-v-activities-from-a-verification-engineer-pov-how-hard-could-it-be. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.