Flaem Nuova operates according to strict operational procedures and exacting production protocols ensuring a high level of quality and integrity of products, with the main objective of end-user safety. The company operates a quality system certified to ISO 9001:2015 and ISO 13485:2016 and in accordance with the requirements of European Directives. Every material used is non-allergenic and biocompatible in compliance with the European Standard EN 10993-1 “Biological Evaluation of medical devices”.

The reliability of products is also guaranteed by the European CE0051 marking and the US FDA registrations. Product quality and strict compliance with applicable regulations is also guaranteed by monitoring product and production system in accordance with the most prestigious international approval Authorities exemplified by MQ, KEMA, TUEV Rheinland and CSA marks.


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