INTELLIGENT ORTHOPEDIC SURGICAL DRILL FOR OPERATING ROOMS

This Class III medical device is an orthopedic power drill with built-in sensing technology that will stop automatically when drilling through bone and prevents the puncturing of important tissues on the back side of the bone that often cannot be seen. PSI was responsible for providing independent verification and wrote test procedures in a requirements-based approach with description of actions to perform, expected results, actual results, pass/fail and date/initials. Drilling was performed using Sawbones® as specimen material with each of the drill bits available for the drill utilized. Exceptions were written when failure conditions existed and a description of the verification and validation activities that took place was produced.

How PSI Helped:

• Independent Verification
• System Testing
• Examined code and matched to testing requirements

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