Dirigeants et représentants réglementaires de i+Med
PÉREZ Raúl
Responsible technician:
To guarantee the conformity of the devices is appropiately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
Masqué
TORRECILLA Josune
PMS and Clinical Trials follow-up responsible:
To guarantee the post-market surveillance obligations are complied in accordance with Article 10(10).
To guarantee the reporting obligations referred to in Articles 87 to 91 are fulfilled.
To guarantee, in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
Masqué
GÓMEZ Laura
Regulatory Affairs Manager:
To guarantee the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.