CLINICAL INVESTIGATION REPORT 1. General This table specifies the contents of the cli ...

Vulnerable population (a) Description of the vulnerable population. (b) Description o ...

Table of contents The table of contents may include the following information:— Centr ...

4.2 Documentation requirements 4.2.1 General: The quality management system documenta ...

7.0 Analytical Studies: The statements and descriptions in the following sections ref ...

7.2.2 Review of requirements related to the product: The manufacturer shall review th ...

(ii) Detailed information: Detailed information should include: (a) complete study pr ...

(ii) Detailed information: Detailed information should include: (a) complete study pr ...