Photo: Nelson Laboratories
Validation & testing is the process of making sure a medical device meets all of the engineering requirements that make up its product requirements. Developers must also track all the data generated from bench-top, in-tissue, animal and human testing.
All medical devices, from simple Class I products to complex Class III devices, must be tested against all product requirements to verify that they meet engineering specifications and are validated to meet product specifications.
During an FDA audit, the device developer must be able to demonstrate that all reasonable tests were done to lower the risks associated with the device.
