Particular requirements for sterile medical devices The manufacturer shall establish ...

Cover page or login screen (1) Name of sponsor or sponsor logo. (2) Clinical investig ...

(ii) Directors, executives and personnel responsible for carrying out evaluation and ...

DUTIES AND FUNCTIONS OF NOTIFIED BODY 1. Duties: 1. Notified body shall perform the a ...

Traceability 7.5.3.2.1 General The manufacturer shall establish documented procedures ...

PROVIDED that no fee shall be required to be paid by the institutes, organisation, h ...

[87A. Registration certificate to sell, stock, exhibit or offer for sale or distribut ...

UNDERTAKING BY THE INVESTIGATOR 1. Full name, address and title of the Principal Inv ...