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

Discover The Projects

Class III Implantable Cardiac 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 5 projects spanning software, 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 LVAD test software code refactoring

Performed code review, maintenance, and refactoring of existing LabVIEW test set source code for a Class III implantable LVAD manufacturer to improve reliability, maintainability, and compliance with quality system requirements.

LVAD production test operational procedures development

Developed operational support procedures for LVAD production test equipment, documenting standard operating procedures to ensure consistent and reliable test execution for Class III medical device manufacturing.

FDA Regulated Medical Device Safety Critical Software Test & Measurement

Implantable cardiac pump programming and test software

Developed pump programming and test software for LVAD device production, enabling automated programming and verification of implantable cardiac pump parameters.

FDA Regulated Medical Device Safety Critical Software Test & Measurement

LVAD test software revision control implementation

Established software revision control and git-ops for test software configuration management, enabling proper version tracking and change control for Class III medical device production test systems.

FDA Regulated Medical Device Safety Critical Software Test & Measurement

LVAD production test data acquisition integration

Developed LabVIEW-based data acquisition integration for left ventricular assist device (LVAD) production test systems, enabling automated measurement and recording of device performance parameters.

FDA Regulated Medical Device Safety Critical Software Test & Measurement

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Project Highlights

Multi-project engagement spanning 5 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, 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.