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Medical Device Software Development
Developing Software for
Regulated Medical Devices
Generating software for medical devices requires more than great code—it demands rigorous processes, deep domain knowledge, and focus on patient safety and privacy. Our team specializes in developing software, firmware, V&V deliverables, and IEC 62304 documentation. We design and deliver FDA-compliant software that accelerates your path to market.
Development Planning
Solutions We Offer
Requirements & Risk Analysis
Architecture & Detailed Design
Implementation and V&V
Maintenance & Problem Resolution
Creation of software development plans capturing SDLC for
Class I, II, and III devices
Integration with overall product design lifecycle and quality system per
21 CFR 820
Preliminary hazard analysis and software dFMEA per ISO 14971
Lead design of embedded system (electronics & firmware) supporting product and cybersecurity needs
UX design for usability and human factors per
IEC 62366 and FDA's guidance document
Design and deployment
of mobile and web-based apps compliant with the FDA SaMD regulations
Robust source code development with peer reviews, static and dynamic analysis
Unit, integration, and software test protocol development, execution and reporting
Software tool validation to ensure reliability and regulatory compliance in development and testing environments
Structured software change management and DHF ripple-effect analysis
Post-market software and cybersecurity surveillance and patching
Long-term support, software maintenance releases, and re-validation
Verifiable software requirements derived from system requirements and user needs
Trace matrix linking requirements to design documents, risk analysis, and test cases
Perform SOUP analysis per IEC 62304 for all third-party components
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