Who we are. How we work.

ecm as independent registrar for applicants.
As Notified Body 0481 in the non-active medical product sector, ecm is the independent contact for manufacturers in the health sector which have to prove that their products conform with specific EU directives. ecm performs for these manufacturers conformity assessment procedures in accordance with Directive 93/42/EC 2003/32/EC and certifies quality management systems in accordance with EN ISO 13485 and related standards (e.g. EN ISO 9001, EN ISO 15378). Our SERVICES section will tell you for which medical devices ecm is your partner for acquiring the CE label or appropiate certificates. Services.

ecm as a competent auditor with potent synergy partners.
The fact that we restrict ourselves to a certain product area, and that our staff can look back on many years of experience in medical device industry mean that we can offer our clients concentrated professional competence. The use of external auditors or experts is reduced to a minimum. A further advantage is our active cooperation in diverse bodies such as national and international standardization committees. This is a guarantee for our clients that ecm is always informed at first hand of the latest formalities. We will inform you pro-actively of these amendments and assist you in complying with these new obligations.

Although ecm does not provide any consultation or laboratory services, the exchange of technical information is possible in all phases of the service provision.

Furthermore, we cooperate closely with specialized laboratories whose services are indispensable for acquiring the desired approvals or certifications. On this sound basis, our qualified staff can carry out its assessment operations efficiently and competently. ecm’s own skilled personnel means flat hierarchies; this in turn makes for short communication routes and decision-making processes. This approach has a long tradition at ecm and it has given us an appropriate reputation as a highly efficient registrar in our sector.

It is easy to find out whether we are the right partner for you. Just define your task, and we will show you the way to CE labelling or certificate. Give us a call, or drop us a line.