Testing is the most important element of any medical device development. Comprehensive and successful testing certainly helps confirming that the product would work as intended and shall be reasonably safe and effective when used. Given that right tests were performed, the product would also get through the approval process swiftly. Everyone recognizes the importance of clinical validation, however there exist some common questions around certification testing.
“What testing should I do for the product?”
“What testing does the FDA want to see?”
“How many tests shall I run for the product?”
“What do I need to perform my testing against?”
The answer to many of these questions lies in the device’s technology and intended use. Here are some typical device characteristics and the corresponding internationally recognized standards that allow thorough planning and execution of testing.