San Diego is a global leader in medical device innovation, home to companies like Dexcom, Illumina, and ResMed. We help medtech companies build software that powers life-saving devices while meeting rigorous regulatory requirements.
The Medical Device Software Challenge
Medical device software is unlike any other software development. It requires exceptional quality, comprehensive documentation, and regulatory compliance that can make or break your product's path to market.
Our Medical Device Software Services
Embedded Firmware Development
Software that runs on the device:
- Real-time operating systems: RTOS development for timing-critical applications
- Sensor integration: Signal processing and data acquisition
- Communication protocols: Bluetooth LE, Wi-Fi, cellular connectivity
- Power management: Battery optimization for portable devices
Companion Mobile Applications
Patient and clinician apps:
- iOS and Android development: Native apps with device connectivity
- Data visualization: Charts, trends, and alerts for health data
- Cloud synchronization: Secure data upload and sharing
- Caregiver access: Family and provider data sharing
Cloud Platforms
Backend infrastructure for connected devices:
- Device management: Fleet monitoring and OTA updates
- Data storage: HIPAA-compliant health data repositories
- Analytics: Population insights and device performance
- Integration: EHR and third-party system connectivity
Regulatory Compliance
FDA Requirements
We build compliance into every phase:
- 21 CFR Part 820: Quality system regulation
- Design Controls: Requirements, design, verification, validation
- Risk Management: ISO 14971 hazard analysis
- Cybersecurity: Pre and post-market security requirements
Documentation
Complete design history file support:
- Software Development Plan
- Software Requirements Specification
- Software Architecture Document
- Traceability Matrix
- Test Protocols and Reports
Ready to build FDA-compliant medical device software? Contact ZIRA Software to discuss your project.