{"id":47,"date":"2023-01-23T19:49:20","date_gmt":"2023-01-23T19:49:20","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/simuarm\/?page_id=47"},"modified":"2023-01-23T19:49:20","modified_gmt":"2023-01-23T19:49:20","slug":"verifications-validations","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/simuarm\/verifications-validations\/","title":{"rendered":"Verifications & Validations"},"content":{"rendered":"\n

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. <\/p>\n\n\n\n

Design Input<\/strong><\/td>Verification & Validation<\/strong><\/td><\/tr>
1<\/td>Verification<\/strong>
Ensure each component is included within the device with design drawing.

Validation<\/strong>
Survey medical professionals and ensure they can locate each component.\u00a0<\/td><\/tr>
2<\/td>Verification<\/strong>
Perform a tensile test on structures following ASTM C1557-20 and ensure tensile strength and stiffness are within specified ranges.\u00a0

Validation<\/strong>
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.<\/td><\/tr>
3<\/td>Verification<\/strong>
Perform a tensile test on structures following ASTM C1557-20 and ensure tensile strength and stiffness is within specified range.\u00a0

Validation<\/strong>
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.<\/td><\/tr>
4<\/td>Verification<\/strong>
Perform a tensile test on structures following ASTM C1557-20 and ensure tensile strength and stiffness are within specified ranges.\u00a0

Validation<\/strong>
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.\u00a0<\/td><\/tr>
5<\/td>Verification\u00a0<\/strong>
Ensure each pathology is included in the device with design drawings

Validation<\/strong>
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.\u00a0
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.<\/td><\/tr>
6<\/td>Verification<\/strong>
Apply force to device and ensure readouts are within the specified ranges.

Validation<\/strong>
Have physical therapist manipulate device at the tricep, bicep, MCL, and LCL and observe whether the force is measured.<\/td><\/tr>
7<\/td>Verification<\/strong>
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<\/strong>
Have physical therapist manipulate device at different loads, flexions and extensions and survey whether correct external feedback is given.<\/td><\/tr>
8<\/td>Verification\u00a0<\/strong>
Measure device and ensure that length and circumferences meet specifications.

Validation<\/strong>
Survey physical therapist users and obtain their feedback.<\/td><\/tr>
9<\/td>Verification<\/strong>
Use a goniometer to measure elbow joint angles at flexion and extension and ensure the measurements meet the specified range.
Validation<\/strong>
Survey physical therapist users and obtain their feedback.<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"

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 … <\/p>\n

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