Event Highlights
We’re excited to share that our team presented a paper, “Software Quality and Compliance in Intelligent Health Monitoring Systems: A Case Study of Baby FM” at the 12th Workshop on Software Quality Analysis, Monitoring, Improvement, and Applications (SQAMIA 2025), held in Maribor, Slovenia, September 10–12, 2025.
- Venue: Maribor, Slovenia
- Dates: September 10–12, 2025
- Workshop: SQAMIA 2025 — 12th Workshop on Software Quality Analysis, Monitoring, Improvement, and Applications
- Proceedings: Published with CEUR-WS
- Paper link: CEUR-WS Proceedings – Paper 7
- Authors: Bojan Gutić, Tamara Papić, and Pavle Dakić
About the Paper
Intelligent health monitoring systems operate in a complex space where reliability, safety, data protection, and regulatory compliance must align with rapid product iteration. Our paper examines these challenges through the lens of Baby FM—a real-world case study—showing how rigorous software quality practices and compliance-by-design principles can be embedded across the lifecycle.
The Baby FM Case Study
The study presents Baby FM as a concrete example of how to:
- Define measurable quality targets tied to clinical and user risks.
- Implement a verification and validation strategy for both conventional and AI-driven components.
- Manage data responsibly across ingestion, storage, model training, and inference.
- Integrate observability and feedback loops to detect quality drift and ensure ongoing compliance.
Highlights include:
- Architecture and process patterns that reduce risk and simplify audits.
- Test automation and coverage strategies for high-signal health events.
- Governance workflows for model updates and documented decision-making.
You can read the full paper here: Software Quality and Compliance in Intelligent Health Monitoring Systems: A Case Study of Baby FM (PDF)
Why This Matters
As intelligent monitoring systems become more capable, the bar for trustworthiness rises. The work demonstrates a practical, reproducible approach to:
- Building user and clinician trust through transparent quality metrics.
- Shortening the path to compliance by embedding controls early.
- Sustaining product velocity without compromising safety.
Acknowledgments
Congratulations to our team—Bojan Gutić, Tamara Papić, and Pavle Dakić—and thanks to the SQAMIA 2025 community for the constructive discussion and feedback in Maribor.
We also thank Idvorski Laboratory for supporting EMC testing under IEC 60601-1 and Axiom International
for providing preliminary precision reports showing 0.1°C accuracy. Clinical Trial data is being collected
under NCT06447337 (https://clinicaltrials.gov/study/NCT06447337)
How to Cite
If you’d like to reference this work, please cite:
- Gutić, B., Papić, T., & Dakić, P. “Software Quality and Compliance in Intelligent Health Monitoring Systems: A Case Study of Baby FM.” In Proceedings of SQAMIA 2025. CEUR-WS. Available at: https://ceur-ws.org/Vol-4077/paper7.pdf
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