Software Validation
Performs software verification and validation for embedded and test system software in accordance with IEC 62304 lifecycle requirements. Supports EEPROM programming, PLC/HMI logic, vision system configuration, and data integrity controls. Conducts code reviews, functional testing, and traceability assessments to ensure software-hardware integration meets safety, performance, and regulatory expectations.
Verified Evidence
Documented case studies demonstrating expertise in Software Validation.
A cardiovascular device manufacturer required validated evidence that production operators could reliably distinguish between acceptable and unacceptable software settings and data entry during Heart-Lung Machine (HLM) production. The challenge involved validating visual inspection methods across multiple software setup categories including function selection, general verification, manual operation, data entry, and password entry. Critical concerns included ensuring operator repeatability and reproducibility across varying software interfaces, preventing software configuration errors that could impact device safety, and maintaining compliance with medical device software validation requirements.
Key Outcomes
- Test Samples:30 Samples
- Operator Agreement:100%