CASE STUDY
Ensuring Precision and Safety for CMR Surgical's Versius Robotic System
Here's how we helped CMR Surgical to prepare the Versius robotic surgical system for medical device certification readiness:
Completion of IEC 62304 audit trail:
The safety critical nature of medical devices demands high standards on software development lifecycle traceability.
As part of an agile team we provided specialized expertise in identifying and closing gaps in test coverage and MISRA compliance of the Versius robotic surgical system's source code running on multiple embedded systems.
Rigorous Completion & Validation: We meticulously verified, validated, and completed the embedded software of the Versius robotic surgical system. This involved using some of the most advanced static code analysis tools and run time profiling tools to identify all gaps in MISRA compliance and to achieve 100% test coverage. This transformed complex code into a robust, reliable, and precise repeatable solution.
Achieving Medical Device Compliance: Our work adhered strictly to the stringent medical device software standard IEC 62304 and MISRA guidelines, guaranteeing that the Versius system's software met all critical regulatory requirements for patient safety and performance.
Delivering Unwavering Reliability: Through comprehensive verification and validation, we ensured the software's integrity and stability, providing CMR Surgical with confidence in their system's precision during critical surgical procedures.