Certifications

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 9001:2008 and ISO 13485:2003 and in accordance with the requirements of European Directives.

Product certifications

The reliability of medical products is also guaranteed by both European CE0051 marking, and by monitoring product and production system in accordance with the most prestigious international approval Authorities exemplified by IMQ, KEMA, TUEV Rheinland, CSA marks which confirm product quality and strict compliance with applicable regulations.
Flaem Nuova certifications also include FDA registration in the U.S. for the aerosol therapy products.