Regulated Medical Device Test Engineering For Global Cochlear Implant Manufacturer

Discover The Projects

Global Cochlear Implant Manufacturer operates under FDA quality system regulation, where every test set, software change, and production tool needs verifiable evidence that it does what its design says it does. Without disciplined non-product software V&V, ATE work that looks finished can quietly become a regulatory liability.

Good Automation engaged across 6 projects spanning verification & validation. Each scope was treated as production-grade work: clean architecture, structured V&V where required, and documentation the customer's own engineers could pick up and extend.

Automated build server and documentation pipeline setup

Established CICD pipeline for medical device manufacturing test software.

FDA V&V documentation gap analysis and assessment

Reviewed and assessed existing V&V documentation against FDA regulatory requirements, identifying gaps and remediation priorities.

FDA Regulated Medical Device Safety Critical Verification & Validation

Test system V&V strategy and architecture consulting

Provided consulting on test system V&V strategy and architecture design for the client's manufacturing test infrastructure.

FDA Regulated Medical Device Safety Critical Verification & Validation

Structured V&V methodology implementation for medical device produc…

Implemented a structured non-product software V&V methodology.

FDA Regulated Medical Device Safety Critical Verification & Validation

Non-product software unit test development

Developed unit tests for software module as part of the non-product software V&V effort.

FDA Regulated Medical Device Safety Critical Verification & Validation

LabVIEW test software utility development

Developed LabVIEW VI helper utilities to support test software development and maintenance workflows.

FDA Regulated Medical Device Safety Critical Verification & Validation

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Project Highlights

Multi-project engagement spanning 6 distinct deliveries for a single customer, a relationship built on repeat work and not one-off scopes.
Capability mix: FDA Regulated, Medical Device, Safety Critical, Verification & Validation.
Work performed in the context of FDA quality system requirements where the customer's regulatory framework demanded it: non-product software V&V per 21 CFR 820.70(i) and electronic-records compliance per 21 CFR Part 11 as applicable.