The preclinical medical device testing is conducted to determine the performance and safety based on the benchmark values. The preclinical data is the performance data obtained from the pre-clinical testing which includes biocompatibility testing, electrical safety testing, mechanical testing, etc. From this, we understand it is the testing of the medical device on the animal or simulated environment other than on the human beings.
Preclinical testing is important in the medical device Technical documentation for the CE marking. For the high risks devices or devices whose clinical data is not deemed appropriate, compliance to the CE marking requirements is demonstrated using those preclinical testing.
Benchmark device is a STANDARD DEVICE with proven quality, safety, regulatory and performance requirements (in market from years) as per applicable International Standards and data on benchmark devices followed by manufacturers to compare and improve the safety and performance of their own devices.
Software validation and verification tests are used as Pre-clinical data for software medical devices.
Standard IEC 82304-1 should be followed for software medical devices to demonstrate risk based approach in technical documentation by addressing software based risks like incorrect data input, inaccurate output and technical failure.