STED vs NMPA vs CSDT Technical Documentation: A Comparative Perspective_Part 2 - September, 2018
- 2020-02-12 15:57:24
It is divided into 12 distinct parts, wherein the 3rd to 11th parts include technical documentations with the following main sections (a) the safety& effectiveness checklist (b) summary of the device (c) research study (d) manufacturing process, (e) clinical evaluation study (f) risk management report (g) technical requirements (h) test reports, and (i) IFU and labels.
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