Preclinical Data of Medical Device

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?