When writing your design inputs for design verification, it is important to keep in mind the following:
-Define the conditions that are most suitable for your device, and how they might change.
-It is critical to ask what your device needs to do and what it needs to go through to achieve its purpose for the patient.
-Make your design inputs are as clear and actionable as possible.
-Ensure that your design inputs are testable, it is important to examine how you will verify each input later in the development process.
The following best practices should be involved in nearly every design validation process:
-The design validation process must include initial production units, the device must be able to be built in the intended production environment, with the exact drawings and specifications.
-Include accurate labeling and packing specifications for use.
-Design validation requires clinical evaluation. The device should be tested in either simulated or actual use by the intended end-user.
-Use and test the medical device under its specific and intended environmental conditions.