Preclinical Data of Medical Device
The preclinical testing of a medical device 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 include the bio compatibility 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 tests are important in the medical device Technical documentation for the CE marking. For the high risks devices or devices whose clinical data is not deemed to appropriate, the compliance to the CE marking requirements are demonstrated using those preclinical testing.
What is a benchmark device? What are preclinical data for the software medical devices?
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.