Certifications

The certifications of the product and the certifications of the system attest the quality of our products and our quality management system. The production environment respects the ISO requirements, and manufacturing controls ensure the quality and safety of our medical devices. All medical devices are CE marked, the quality system is certified UNI EN ISO 9001/2008 and UNI CEI EN ISO 13485/2012.

Medifly has the following certifications:

  • Quality system: UNI EN ISO 9001:2008
  • manufacture of medical devices: UNI EN ISO 13485:2012
  • CE marking on medical devices
  • tubes for the beverage industry (NSF51 certification on ACCUAFLY™ tubes and tests effected directly on PELD tubes for compliance with DM 174 dated 06.04.04)
  • oxygen barrier tubes

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