Regulated Medical Device Test Engineering For Class III LVAD Manufacturer

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Class III LVAD 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 10 projects spanning software, 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.

Class III LVAD life cycle tester gap analysis

Performed a gap analysis of the life cycle tester (LCT) HMI software for a Class III Active Implantable Medical Device (AIMD) LVAD manufacturer operating under an FDA warning letter.

On-site Class III LVAD tester V&V consulting

Delivered on-site V&V consulting and training for the Life Cycle Tester used in Class III LVAD implant life cycle testing.

FDA Regulated Medical Device Safety Critical Software Verification & Validation

Life cycle tester requirements traceability matrix development

Developed requirements traceability matrices linking requirements, design, tests, and results for the Life Cycle Tester V&V documentation.

FDA Regulated Medical Device Safety Critical Software Verification & Validation

LVAD test software component reverse engineering assessment

Reverse engineered and assessed software component SP00381 to establish requirements and traceability for V&V remediation.

FDA Regulated Medical Device Safety Critical Software Verification & Validation

LVAD test software requirements recovery assessment

Performed reverse engineering assessment of software component SP00397 for requirements recovery and gap remediation.

FDA Regulated Medical Device Safety Critical Software Verification & Validation

Life cycle tester revision-level V&V gap analysis

Conducted a revision-level gap analysis to identify missing V&V documentation and compliance artifacts for the LCT.

FDA Regulated Medical Device Safety Critical Software Verification & Validation

Life cycle tester firmware FDA gap analysis

Performed firmware gap analysis against FDA requirements for the Life Cycle Tester HMI software.

FDA Regulated Medical Device Safety Critical Software Verification & Validation

LabVIEW coding standard for class III medical device maker

Developed a comprehensive LabVIEW coding standard ensuring consistent, maintainable, and compliant test software development for a Class III LVAD manufacturer.

FDA Regulated Medical Device Safety Critical Software Verification & Validation

Automated PDF test report generation toolkit

Created a PDF reporting toolkit enabling automated generation of formatted test reports from LabVIEW test applications.

FDA Regulated Medical Device Safety Critical Software Verification & Validation

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Project Highlights

Multi-project engagement spanning 10 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.