What Should Be Included In The Research Data Of Active Medical Devices’ Service Life?

The administrative counterparts shall submit an analysis and evaluation report on the service life of the product. The report shall specify the evaluation method, evaluation path, influencing factors and evaluation method, as well as the corresponding verification data. The verification data can be accelerated/real-time aging test data, empirical data, and other verification/validation data generated through reliability analysis method, simulation test method or other theoretical and simulation calculation methods.