Verification and Validation

Did we make the right device? Did we make the device right?

Verification

Engineering/bench testing – One-to-one measure of design input against design output. Engineering and bench testing takes your requirements as defined in your risk management and product requirements (design input) and tests and measures them against specification.


Validation

Cleaning/disinfection – Cleaning and disinfection measures user needs against design output. Devices can carry bacteria and viruses and spread disease. Depending on where and how your device is to be used, you should use materials that will withstand standard cleaning and disinfection methods. Make sure the device you produce will last a reasonable amount of time in its intended environment while helping to prevent the spread of disease.