Regulated Medical Device Test Engineering For Fortune 500 Medical Device Manufacturer

Discover The Projects

Fortune 500 Medical Device 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 2 projects spanning manufacturing, 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.

Production gantry test system software validation

Performed software validation for the gantry-based production test system used in medical device manufacturing.

Production multirun test station V&V support

Supported verification and validation of the multirun test station for medical device production line testing.

FDA Regulated Manufacturing Medical Device Verification & Validation

Long-Lived Deliverables

Systems designed to be sustained by the customer's own engineers for years after handoff, with no integrator lock-in and no opaque components.

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Project Highlights

2-project engagement covering complementary scopes under one engineering relationship.
Capability mix: FDA Regulated, Manufacturing, Medical Device, 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.