How to write the technical evaluation of medical device products?

the product technical report shall include the following contents:

(1) product features, working principle, structural composition and expected use;

(2) the basis for determining the product technical indicators or main performance requirements;

(3) product design control, development and research process;

(4) the main process flow and description of the product;

(5) product testing and clinical trials;

(6) Comparative analysis with similar products at home and abroad.

the technical report discusses the above contents and provides experimental data or documentary evidence.