Mechanical testing is critical: It meets the requirements of regulatory agencies to bring your medical device to market, and it proves your device is safe and does what it’s designed to do.
The results from mechanical testing provide the measure of safety and efficacy needed for the submission, either for a 510(k) device comparison or to show that the device will not cause harm during clinical trials.
Mechanical testing can follow a customer-provided protocol, an internationally recognized ASTM or ISO test standard, or a co-developed custom protocol. The goal of any mechanical testing should be to answer specific questions about the strength and performance of the device being evaluated. Correctly identifying the questions and therefore the methodology to answer the questions is as imperative as the testing itself.
Thorough planning, including timelines, testing goals, protocol development, costs (including specimen manufacturing) and acceptance criteria will help to ensure that any mechanical testing battery will be successful.