Medical Devices
Software That Powers Life-Saving Technology
We develop embedded software, companion apps, and cloud platforms for medical devices—built to FDA standards with quality and safety at the core.
Discuss Your ProjectIndustry
Challenges.
We understand the unique obstacles your industry faces. Our experience allows us to anticipate challenges and deliver solutions that work.
Meeting FDA 21 CFR Part 11 and IEC 62304 compliance requirements
Implementing rigorous software development lifecycles with full traceability
Ensuring real-time performance and reliability in critical applications
Managing complex hardware-software integration and testing
Supporting regulatory submissions and post-market surveillance
How We
Help.
Embedded Device Software
Real-time, safety-critical software for diagnostic equipment, monitors, and therapeutic devices.
Companion Mobile Apps
iOS and Android applications that interface with medical devices for data display, control, and sharing.
Cloud Data Platforms
Secure cloud infrastructure for device data aggregation, analysis, and remote monitoring.
Regulatory Documentation
Complete software documentation packages including design history files and risk analysis.
Quality Management Systems
Implementation of ISO 13485-compliant QMS processes for continuous quality assurance.
Cybersecurity Assessment
Threat modeling and security testing aligned with FDA premarket cybersecurity guidance.
Diagnostic Device Manufacturer
Achieved FDA 510(k) clearance in 8 months with zero major findings during audit.
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Let's discuss how we can help you overcome challenges and achieve your goals with custom technology solutions.
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