About ECM
ECM Medical Device Testing & Certification
ECM (Ente Certificazione
ECM is headquartered is in Italy with presences in the USA, Canada, Korea, Japan, China Mainland, India
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.
Our commitment to customer service and operational efficiency shortens time to market for medical devices and improves patient lives. What sets ECM apart is:
Efficiency – Solutions tailored to your needs
Time to Market Matters – Approvals in weeks rather than months
Experience Matters - Notified Body expert for testing, inspection, and certification
Accredited tests are recorded on the website www.accredia.it

ECM is an official Notified Body for products falling under the European directives for:
93/42/EEC - Medical Devices Directive
2014/68/EU - Pressure Equipment Directive
2014/34/UE - ATEX certification
2014/30/EU – EMC (Electromagnetic compatibility) Directive
2006/42/EC - Machinery Directive
2014/35/EU - Low Voltage Directive
2014/33/UE – Lift Directive
Authorized for German GS-mark certification
ECM maintains various national accreditations:
Product certification according to ISO/IEC 17065
Management system certification to ISO/IEC 17021
Testing services according to ISO/IEC 17025
Training
The associated laboratories have accreditations by Russian GOSSTANDART, Chinese CNAS, Korean RRL, Australian NATA, German ZLS, Canadian SCC
Ente Certificazione Macchine
Via Cà Bella, 243
40053 Valsamoggia
Location Castello di Serravalle (Bo) Italy
P. +39 051 6705141
F. +39 051 6705156
Let's talk about
ECM America -Unit 506 – 1110 Brickell Avenue 33131
Miami, Fl
ECM HQ - Via Ca' Bella, 243, 40050
Valsamoggia (BO)