Who we are
ECM has a twenty-year of experience in the certification of products, machinery and work equipment, positioning itself as a point of reference for international companies in the verification of compliance with the standards imposed by EU directives and major international standards.
Through its 4 operational divisions – pecertification, laboratory tests, inspection and training – ECM is able to offer a wide range of quality and safety services.
ECM – Ente Certificazione Macchine was founded in 1998 at Savignano sul Panaro (MO), Italy.
Subsequently, thanks to constant expansion, the company decided to move and build its headquarters in Castello di Serravalle – Valsamoggia (BO), where it currently resides.
The attention to the international context has led ECM to expand its presence globally, through the creation of a dense network of commercial partnerships in China, South Korea, Vietnam, Singapore, Iran, India, Israel and United States.
Over the years, ECM has expanded its areas of expertise by obtaining accreditation as a Notified Body for various European Product Directives and as an accredited Testing Laboratory. ECM has also been appointed as NCB, to operate within the international CB IECEE scheme.
In February 2017 ECM, formerly Notified Body for 6 European Product Directives, obtained accreditation from the Ministry of Health to issue the CE certification pursuant to the Medical Devices Directive 93/42 / EC. In addition, it is qualified as a body for the certification of Quality Management Systems in accordance with the ISO 13485 standard. In 2020, continuing to broaden its service portfolio, ECM gained accreditation for the RED Directive 2014/53/UE.
In just over two years, following a considerable increase in the activity of the Medical Devices Divisione, ECM decided to further expand its structure, through the construction of a new building, next to the current Valsamoggia headquarters. In the new headquarters of ECM for Medical Devices, inaugurated in July 2020, there is also an extension of the Testing Laboratory, with new advanced equipment and tools, including a last generation semi-anechoic chamber.
After a long evaluation process carried out by the relevant national and international authorities and intensive work by the entire ECM staff, in 2022 Ente Certificazione Macchine obtained the designation as Notified Body for the European Medical Devices Regulation 2017/745 (MDR).