Automating Verification Evidence for a Connected Device
Specialized Engineering Scope & Mission Challenge
A connected medical technology enterprise manufacturing infusion pumps faced ballooning release cycles. As software complexity expanded with cloud telemetry, cybersecurity patches, and mobile app companion interfaces, the manual verification effort exploded. Verification engineers spent eight weeks per release cycle executing manual regression scripts on bench fixtures and copying screenshots into Word documents to satisfy FDA 21 CFR Part 11 and EU MDR audit requirements. Engineering teams were burned out, and critical clinical feature updates were delayed by months.
Granular Competency & Technical Requirement Matrix
Critical Engineering & Integration Complexities
- Rigorous 21 CFR Part 11 compliance mandating tamper-proof audit trails and cryptographic signatures on all automated test logs.
- Interfacing automated test scripts with physical touchscreens, physical keypad buttons, and real fluid flow sensors.
- Ensuring test framework reliability to eliminate flaky tests that invalidate multi-hour regression runs.
- Supporting continuous agile release cycles while maintaining complete compliance with formal medical device DHF freeze gates.
Engineered Delivery & Execution Workflow
Test Infrastructure Architecture
Architected a modular Python test harness controlling programmable power supplies, serial lines, and fluid sensors.
Electronic Record Hardening
Implemented cryptographic SHA-256 hashing and automated timestamping for all generated execution logs and artifacts.
Automated Infusion Testing
Scripted automated test suites covering bolus delivery accuracy, occlusion alarm triggers, and air-in-line detection.
Polarion ALM Bi-Directional Sync
Automated the synchronisation between Polarion requirements, test cases, and automated execution results.
Stress & Boundary Fuzzing
Implemented network fuzzing and memory leak checks under 72-hour continuous pumping stress scenarios.
Audit Dossier Generation
Built an automated compilation script that transforms thousands of test results into a single indexed, audit-ready PDF dossier.
Regulatory Validation & Handover
Validated the test tool itself in accordance with FDA software validation guidelines for release use.
Production Toolchains, Protocols & Frameworks
06 | PROJECT TARGETS
Project Targets and Business Impact
Customer Confidentiality Note: Customer identity, proprietary codebases, and commercial program specifics have been anonymized in accordance with non-disclosure agreements.