Verification and Validation are important aspects when it comes to design control. The verifications are used to test the specifications and they demonstrate that device is being built correctly at all times. Validations are used to test the requirements and ensure that the device function correctly. Each design input gets a verification and validation activity. While our final protocols have not been written yet, the table below features the planned activities for each design input.
| Design Input | Verification & Validation |
| 1 | Verification Ensure each component is included within the device with design drawing. Validation Survey medical professionals and ensure they can locate each component. |
| 2 | Verification Perform a tensile test on structures following ASTM C1557-20 and ensure tensile strength and stiffness are within specified ranges. Validation Survey physical therapist and have them rank the feel on a scaled basis: 1-5, 1 being does not feel like a human muscle and 5 being feels like a human muscle. |
| 3 | Verification Perform a tensile test on structures following ASTM C1557-20 and ensure tensile strength and stiffness is within specified range. Validation Survey physical therapist and have them rank the feel on a scaled basis: 1 being does not feel like a human tendon and 5 being feels like a human tendon. |
| 4 | Verification Perform a tensile test on structures following ASTM C1557-20 and ensure tensile strength and stiffness are within specified ranges. Validation Survey physical therapist and have them rank the feel on a scaled basis: 1 being does not feel like a human ligament and 5 being feels like a human ligament. |
| 5 | Verification Ensure each pathology is included in the device with design drawings Validation Have physical therapists perform varus/valgus stability tests for normal physiology, torn MCL, and torn LCL, survey them on scaled basis: 1 being does not feel like a torn human ligament and 5 being feels like a torn human ligament. Have medical professionals perform a joint reduction on model and survey them on how similar it feels to reduction done on human: 1 being does not feel like a joint reduction and 5 being feels like a joint reduction. |
| 6 | Verification Apply force to device and ensure readouts are within the specified ranges. Validation Have physical therapist manipulate device at the tricep, bicep, MCL, and LCL and observe whether the force is measured. |
| 7 | Verification Manipulate device to specified ranges of load, flexion, and extension and ensure that the visual and audio cues in compliance with IEC 60601-1 7.8.1 2012 are given. Validation Have physical therapist manipulate device at different loads, flexions and extensions and survey whether correct external feedback is given. |
| 8 | Verification Measure device and ensure that length and circumferences meet specifications. Validation Survey physical therapist users and obtain their feedback. |
| 9 | Verification Use a goniometer to measure elbow joint angles at flexion and extension and ensure the measurements meet the specified range. Validation Survey physical therapist users and obtain their feedback. |