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.
- 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.
- 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.
- 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.