Certifications

Therefore, those who choose SEDA choose a reliable partner, certified to UNI CEI EN ISO 13485:2016 and UNI CEI EN ISO 9001:2015 standards, capable of demonstrating the compliance of its products and services at any time.

All our suppliers have been assessed by Notified Bodies authorised and designated by the Member States of the European Union to assess the conformity of medical devices with Regulation (EU) 2017/745 (Medical Device Regulation, MDR) and have obtained the CE marking for the products supplied.