Regulated Medical Device Test Engineering For Global Test Equipment OEM

Discover The Projects

Global Test Equipment OEM 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 test & measurement, 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.

Global FDA compliance and medical device sales training

Flew to the client's headquarters in Penang, Malaysia to train a global team on FDA compliance, test method validation, and how to sell into the medical device and life science industries.

Regulated instrument verification and validation

Performed verification and validation test instrumentation OEM.

Aerospace Defense FDA Regulated Medical Device Test & Measurement 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: Aerospace, Defense, FDA Regulated, Medical Device, Test & Measurement, 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.