Medical Device Commercialization Overview

Validate the Design

Design validation testing is intended to “ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.”

You will need to perform design validation testing in order to prove that the device as designed can perform its intended functions under the conditions in which it will be used. Validation considers not only the device itself, but also stresses imposed on the device and on the user by the environment (heat, humidity, cold, distraction, etc.). Product packaging and labeling also needs to be included in validation testing.