A Comprehensive Approach for Software Quality Assurance for Medical Systems

The growing role of software in medical processes emphasizes its critical function in ensuring safety during diagnosis, decision-making, and device operation. Recent efforts focus on establishing robust software life cycles and adhering to certification standards through thorough verification and validation. This work explores methodologies for developing medical devices, highlighting the efficacy of model-based system engineering (MBSE) for compliance. Furthermore, Combinatorial Interaction Testing proves beneficial for complex systems, as demonstrated in case studies like the MVM ventilator, Pill-Box, and PHD protocol. Finally, for medical software integrating artificial intelligence (AI), alternative methods based on neural network robustness analysis are proposed for validation.