Example build · an illustrative blueprint, not a client case study
Medical Devices & MedTechCompanion app for a connected medical device
A MedTech team with a Bluetooth device needs the app, the cloud and the clinician dashboard around it, documented for their quality system.
The device works; the software around it does not exist yet. Readings must sync reliably from cheap phones, clinicians need trends and alerts, and every change has to be traceable for the regulatory file.
- Patients pairing and using the device at home
- Clinicians reviewing readings and alerts
- The quality and regulatory team maintaining the design history file
Scope for the first release
- 01BLE pairing and sync that survives app restarts and flaky phones
- 02Offline storage with conflict-free upload when back online
- 03Clinician dashboard with trends, thresholds and alerting
- 04Device fleet view: firmware versions, battery, last sync
- 05Requirements-to-test traceability matrix and verification test suite
- 06Audit trail with e-signatures for configuration changes
How it would run
- Week 1
Requirements and risk
Software requirements, risk analysis inputs and the BLE protocol walkthrough with the firmware team.
- Weeks 2–5
Build and verify
BLE layer and sync first, then cloud ingestion and alerts, then the clinician dashboard, with tests written alongside each requirement.
- Week 6
Verification release
Run the verification suite, export the traceability matrix, deploy a validated build for the clinical pilot.
- Mobile
- Native Swift and Kotlin BLE modules inside React Native
- API
- Python (FastAPI), TimescaleDB
- Dashboard
- React, TypeScript
- Quality
- Requirements tracing in your QMS tool, automated test reports
- Cloud
- AWS or Azure with audit logging
- iOS and Android companion apps
- Cloud backend and clinician dashboard
- IEC 62304-style documentation package for your QMS
- Source code, tests and infrastructure in your accounts
- Over-the-air firmware updates
- Integration with hospital EHRs via FHIR
- Data export for clinical studies
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