Mock-OR validation for a next-generation surgical robot

Leading medical device manufacturer developing a next-generation surgical robot for minimally invasive procedures.

Validate that surgeons could safely operate the device console in high-stress OR environments, with particular focus on critical use errors in instrument insertion and hand-control calibration.

Identified critical use errors in surgical workflows. Designed a mock-OR protocol with sterile-field fidelity to surface real-world pain points. Supported summative validation aligned to IEC 62366-1 and ISO 14971.

• •Identified 30+ critical use errors across formative phases
• •Majority of identified errors mitigated through design controls
• •Supported successful FDA 510(k) submission with HFE/UE file