The company has a Quality Assurance department thanks to which it is able to produce and manage, in an autonomous manner, all the documentation needed to obtain the CE mark.

Checks

  • SIDAM’s personnel carry out checks on all purchased components in order to ensure compliance with the internal procedures implemented by the Quality Assurance Managers.
  • Prior to the sterilisation, all finished products undergo tests and inspections for the purpose of guaranteeing top quality and proper operation.

Sterilisations

  • Sterilisation activities are carried out by a qualified partners, for both the sterilisations with ETO and those with Beta/Gamma rays.

Checks pertaining to the sterilisations are conducted by a MIUR-certified laboratory.

Certifications

  • EN ISO 13485:2016.
  • Marchio CE.
  • Certificazione dal Ministero della Salute Giapponese.
  • Marchio CE per la distribuzione vendita in Canada.
  • Anvisa certification per il prodotto Nutrivent in Brasile.
  • FDA ottenuta per un OEM cliente.
  • ISO 9001:200 and ISO 13485:2003.
  • CE Marking.
  • Certification by the Japanese Ministry of Health.
  • CE mark for distribution and sale in Canada.
  • Anvisa certification for the Nutrivent product in Brazil.
  • FDA obtained for an OEM customer.

We are also taking steps for implementing all the necessary activities for the purpose of obtaining the FDA certification for all products.