WP5: Industrial-oriented process


The objective of this work package is to establish and perform, from the beginning of the project, a common method and path to reach the CE label immediately after the end of the project. (Task 5.1 to Task 5.4) The work package will also consider preparation of a clinical protocol to be submitted to the ethical committee once obtained the CE mark (Task 5.5 - Clinical protocol and documents for ethical committee). To meet these objectives, the work package is divided into the following aims:

Task 5.1 – Industrial labelling pathway definition for CE mark (EKYMED, OVE)
Task 5.2 – Pre–compliance testing for CE mark (EKYMED, SSSA, UCL, OVE)
Task 5.3 – CE mark technical file compilation (EKYMED, SSSA, UCL, OVE)
Task 5.4 – CE mark test (EKYMED, OVE)
Task 5.5 – Clinical protocol and documents for ethical committee (UNITO, UEDIN)

EKYMED will be the WP leader