ECM America

ECM America (Ente Certificazione Macchine) is a Notified Body (#1282) and an accredited ISO 13485 Certification Body supporting European market access for medical devices and other products. Through offices, laboratories and an extensive partner network in Asia, North America, Europe, Middle East, ECM delivers reliable, efficient and responsive services.

ECM is headquartered is in Italy with presences in the USA, Canada, Korea, Japan, China Mainland, India and Iran. Our laboratory in Italy together with our associated labs, are accepted for testing within many international schemes. Medical Device CE Mark certification is offered from our Italian HQ through local service in ...