ECM (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. Certification of products to the European Directives is offered through our head office in Italy.

Our team of professionals (of which over 65% are engineers) is dedicated to helping manufacturers bring safe and quality medical devices to global markets through our efficient testing and certification programs.