Medical device

Legislative compliance marks for the free and safe movement of products

A long history of specific expertise and dedicated services to the medical devices industry sets us apart.

Since the 1990s, Certiquality has been among the leading players in Italy and Europe as a notified body for the issuance of the legislative conformity mark for the free and safe movement of products. As of October 2021, CQY has obtained the new notification for European Regulation MDR 2017/745. CQY also offers quality system certification services against the ISO 13485 standard.

Medical Devices services

REG. 2017/745 (MDR)

Certiquality carries out verifications for the issue of CE certification of medical devices according to the product classes listed on the NANDO portal.

ISO 13485

ISO 13485: Certiquality supports companies that design, develop, manufacture, install medical devices and provide related services in compliance with European directives.