Regulated Medical Device Test Engineering For Class III Cardiac Support Device Manufacturer

Discover The Projects

Class III Cardiac Support 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 test & measurement. 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.

Class III cardiac support device test software upgrade

Updated production test software for the second-generation cardiac support device -- a Class III device that holds the heart during open-heart surgery, cools it, and pumps blood through the body to maintain circulation.

Third-generation cardiac support device production test software

Designed and developed new test software for the third-generation cardiac support device production testing.

FDA Regulated Medical Device Safety Critical Test & Measurement

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, Medical Device, Safety Critical, Test & Measurement.
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.