SAS obtains a second certification to ISO 13485 by French Notified Body, GMED NoBo0459, in addition to the 2009 recognition of its Quality Management System by Norwegian Notified Body, DNV GL Presage NoBo2460. Clariance will therefore again successfully pass the initial certification audit conducted by GMED for its ISO 13485:2016 certification. This standard states the requirements for the quality management system when an organization must demonstrate its ability to provide medical devices and associated services on a regular basis in accordance with client requirements and applicable regulatory requirements.
Willy Vivanz, CTO and Site Manager, recalls, “This was not only an initial onsite certification audit, but also an evaluation of four new implantable medical devices prior to their first debut on the market according to MDD 93/43/EEC.” This double certification reflects Clariance’s ability to maintain a Quality Management System that complies with regulatory requirements and whose processes guarantee the provision of solutions whose safety and clinical performance are in line with our claims, the standards of our practitioners and the satisfaction of their patients.
Thierry Manceau, General Director, adds, “At a time when the capacity of Notified Bodies is being challenged by an influx of new certification applications due to the implementation of the new European regulation MDR 2017/745, this ISO certification is a big win and a direct result of our team’s hard work. It is a demanding, internationally recognized certification that not only facilitates the registration of our medical devices in Europe, but is also an essential standard in our field of activity.”