The idea

ChestPal started with a simple question: could a centuries-old tool — the stethoscope — be made more objective, reliable and on par with modern clinical technologies?

ChestPal built an answer — a smart stethoscope powered by a proprietary lung sound recognition engine, designed to help detect respiratory irregularities. The device caught the attention of frontline healthcare providers — being able to flag subtle lung sounds could play a meaningful role in clinical practices.

While the core technology was validated, adapting it to comply with the stringent regulatory framework governing software as a medical device in the U.S. market required further engineering and quality processes.

AI Consulting Services

The gap

ChestPal’s hardware and sound recognition engine were proven. But the software layer — the user-facing apps, backend, and documentation needed to bring it all to market — wasn’t there yet.

ChestPal came to Oxagile with:

  • Alpha-stage mobile apps (iOS and Android)
  • Legacy monolithic backend
  • Early-stage software documentation

The gap between the two? That’s where Oxagile came in.

The destination was clear: alignment with applicable U.S. medical device requirements alongside market-ready applications.

The journey

This wasn’t about reinventing ChestPal’s product. It was about hardening the software stack and making it market ready.

Oxagile partnered closely with ChestPal’s in-house RA/QA team, combining regulatory expertise on the client side with engineering execution from Oxagile. It quickly became one of those partnerships where everything just clicked — open communication, mutual trust and zero friction.

Mobile applications

Native iOS and Android apps – refactored, stabilized, and polished for release. Improved BLE connectivity with the stethoscope device, optimized audio streaming pipeline, and refined UX for clinical workflows.

Backend and infrastructure

Legacy monolith decomposed into a microservices architecture. Cloud-native deployment with auto-scaling, load balancing, and high availability. RESTful API layer redesigned for better performance and maintainability.

Security and compliance

End-to-end encryption for data at rest and in transit. Role-based access control, audit logging, and secure authentication flows. Full alignment with HIPAA and GDPR requirements.

Documentation and regulatory prep

Software architecture documents, risk analysis, traceability matrices, and test protocols — all built to meet IEC 62304 (medical device software lifecycle) and applicable U.S. medical device requirements for the software components.

The destination

Where it started
icon

Alpha apps

icon

Monolithic legacy backend

icon

Early-stage software documentation

icon

Pre-compliance software stack

Where it landed
icon

Production-ready iOS & Android releases

icon

Scalable microservices architecture

icon

Full IEC 62304 + U.S. medical device documentation

icon

HIPAA & GDPR compliant, audit-ready

The takeaway

“Quality engineering is table stakes. What set Oxagile apart is that they treated our product like their own — flagging UX edge cases we hadn't considered, digging into FDA documentation at a depth rarely required for non-medical products and being honest about estimates from day one — even when it could have been easy to bill more hours. Perhaps most importantly, I know that if we need them tomorrow — even between engagements — they’ll show up. You can't put a price on that.”
— Helena Binetskaya, ChestPal co-founder and Chief Product Officer

Sometimes impact isn’t about building something new.

It’s about taking something promising — and making it ready for the world.

AI Consulting Services

Let's make your health software market-ready

We help MedTech teams turn validated prototypes into secure, compliant, production-ready systems.

Get started