I fully agree with this. There are various test that can be done to physically test a device. Instron testing to test mechanical properties, environmental testing to test how a product reacts in certain temperature conditions and for shelf life, packaging testing to test how a product that is packaged reacts to wear and tear as it is delivered. To expand on the statistics part, any test on a medical device should have a statistical analysis or test backing it. This is highly important since it helps support whatever test method is created and provides proof that the test is valid. A Gage R&R is a good way to prove repeatability and reproducability in a process and identifying if variation is within part-to-part or within the different inspectors or operators. In addition, doing a capability analysis is a very useful way to detect whether your system is able to meet certain specs and requirements. This is extremely using if you are testing whether a measurement for a part of a device falls within the min or max of a spec and tolerance. Both of these statistical analysis tools are powerful for demonstrating the extent of improvements made within a process or system.