Certifications

Flaem Nuova’s products are tested in accordance with to international safety standards, to guarantee users compliance with the requirements of current European directives and/or regulations.

The company has a certified quality system according to the ISO 9001 and ISO 13485 standards (specific for medical devices): the implemented procedures guarantee and ensure high standards of reliability.

At the beginning of 2023, the company obtained the "EU Quality Management System Certificate", in accordance with the new MDR, Regulation (EU) 2017/745 for medical devices.

Flaem has been working for years with various bodies such as IMQ, TÜV Rheinland and Intertek, as well as with a series of accredited laboratories, to carry out specific tests, all aimed at ensuring compliance and maintenance of the requirements necessary to ensure the CE marking of its devices.

All products destined for the USA are registered with the FDA (USA Food and Drug Administration).