Software Development
We support every phase of the medical device software lifecycle, delivering turnkey solutions from requirements definition through design, implementation, testing, and certification support. Our teams are experienced in both Agile and Waterfall methodologies, and Critical Software is certified by the CMMI Institute for its use of both models.
We apply best-in-class project management practices, including PMI, Six Sigma, and Earned Value Management (EVM), ensuring that each project meets its defined scope, timeline, and quality targets.
Requirements engineering
Understanding complex requirements is essential to avoid costly delays. We’ve built a robust process for defining software requirements, product vision, traceability, and configuration management—ensuring alignment with regulatory and business goals.
Systems and software engineering
We design, develop, test, and maintain embedded and application-level software, including board support packages, firmware, bootloaders, and embedded operating systems. Our work complies with IEC 60601, IEC 62304, and IEC 82304, and we deliver software classified under Safety Classes A, B, and C.
We also support legacy system evolution through gap analysis, reverse engineering, and re-design.
User interface & user experience design
We integrate UX design throughout development to reduce user error and improve safety. Our approach includes contextual design, cognitive workload analysis, and regulatory compliance. We use design thinking, service design, and usability testing to ensure solutions are intuitive and effective.
