Quality management
Certification of the quality management system applicable to medical device manufacturers according to the ISO 13485 standard.
All distributors, subcontractors of products and services related to medical devices.
All manufacturers placing medical devices on the market in accordance with European directives on medical devices and in vitro diagnostic devices.
An auditor or team of auditors with proven experience in the field of medical devices and the associated European directives, qualified according to the new accreditation rules on competency.
Certification has a regulatory dimension for certain classes of medical devices, enabling their first placement on the European market. In this case it complements the CE marking.
Our teams are available to provide you with information and advice.
Main site :
14, Avenue de l’Europe,
Regus – Floor 3
77144 Montévrain, France
Tel : 00 33 160 428 948
Headquarter :
1710 Chemin de la Decelle, Drome Sud Provence business park
26130 Saint-Paul-Trois-Châteaux, France