Sofemed International

• Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
  BelgiqueContacter l’autorité →

Aucun certificat enregistré pour ce fabricant.

4 contacts identifiés

• FA
  FESSI Asma

  PCVRR
  Voir le profil →
• GE
  GUIRAT Emna

  PCVRR
  Voir le profil →
• FESSI Asma
  - Ensure that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date -Ensure that the post-market surveillance obligations are complied with in accordance with Article 10(10) -Ensure that the reporting obligations referred to in Articles 87 to 91 [Article 82 and 86 of the IVDR] are fulfilled -in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV [Section 4.1 of Annex XIV of the IVDR] is issued
  Masqué
• GUIRAT Emna
  Ensure the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
  Masqué

• FESSI Asma — Sofemed International
• GUIRAT Emna — Sofemed International

Aucun dispositif enregistré pour ce fabricant.