We guarantee activities and prepare dossiers manufacturers, representatives and distributors need to market medical devices and in vitro diagnostic devices (IVD).

We guarantee the fulfilment of the requirements to the devices could be purchased. We prepared the notification of medical devices to the competent authorities before the start of marketing.

We guarantee the wording for the labelling and instructions for use of medical devices in the Portuguese language and we respect the nº13 of Annex I of the Decree 145/2009 of 17 June.

In the case of active implantable medical devices, we assure the fulfilment of stipulated in paragraphs 17,18 and 19 of Annex X of Decree-Law 145/2009 of 17 June.

We ensure the fulfillment of obligations of the distributor of medical devices near the regulatory authorities: the notification of the list of devices placed on the market by the distributor, the name or business name and the official address of the manufacturer or authorized agent, the name or business name changes, the domicile and address complete and other elements compulsorily notifiable.