Case Study: ChestPal achieves FDA-ready, production-ready medical software with Oxagile

ChestPal launches FDA-ready medical software with Oxagile

ChestPal, a developer of a smart stethoscope with a proprietary lung sound recognition engine, had validated its core technology but faced the challenge of making its alpha-stage software compliant with stringent U.S. medical device regulations. They partnered with Oxagile, which provided engineering and quality process services, to bridge the gap between their proven hardware and a market-ready, compliant software stack.

Oxagile refactored the mobile apps, decomposed the legacy backend into a scalable microservices architecture, and implemented end-to-end security compliant with HIPAA and GDPR. The solution delivered production-ready applications and full IEC 62304 documentation, making the software audit-ready and fully aligned with U.S. medical device requirements.

ChestPal