Who we are. How we work.
ecm - Zertifizierungsgesellschaft für Medizinprodukte mbH - was founded in 1994 in Aachen. Since then, ecm has been primarily supporting SMEs in Germany and the European economic area within the scope of certification and conformity assessment procedures.
Our company philosophy is characterised by the idea of supporting our customers as an optimal partner from the first contact through the application as well as during the certification process until the end of the validity of the certificates.
This means, in particular, to adequately meet our surveillance obligation in terms of product quality and patient protection at all times. For this purpose, the focus, scope, and depth of the upcoming tasks are transparently defined in each individual case - in accordance with the respective product and technology risks and the given assessment framework. Thanks to a flat hierarchy, we offer our customers direct communication and short decision-making paths, thus guaranteeing the valued customer proximity.
Activity as Notified Body
Until 25 May 2020, ecm was notified as Notified Body for the issue of certificates according to RL 93/42/EEC. Certificates that are still valid are currently monitored by ecm on a civil contractual basis, due to current case law. Since the date of application of Regulation (EU) 2017/745 (MDR), taking into account the transitional provision of Article 120 of this Regulation. As a central objective, ecm is currently applying for notification according to MDR. Due to the complexity of this task and the inhibiting influences of the Corona epidemic, a clear prognosis of the temporal course of this project is not possible at the moment. The intended scope has not yet been finally defined, but will initially certainly not include all product groups and risk classes of the previous designation.
Other certification of management systems
In addition to its previous activities as a Notified Body, ecm has also been active as a certification body for management systems according to DIN EN ISO 13485 for almost two decades. In January 2021, an application for accreditation was submitted to the German Accreditation Body (DAkkS). This is to objectively prove the quality of our work as well as the competence of the ecm staff and at the same time lead to a stronger acceptance of such certificates in the national and international environment. ecm expects to obtain the granting of accreditation in the course of the second half of 2021.
Until October 2020, Mr. Jörg Wilke was the sole shareholder of ecm and available to customers as managing director and contact person for more than 20 years. On 1 November 2020, Mr. Ralf Classen succeeded Mr. Wilke as managing director and head of the certification body after more than a decade of activity for ecm.
On the shareholder level, Mr. Simon Dietz (PhD) now represents the interests of ecm in place of Mr. Wilke since 1 January 2021. Mr. Dietz is known as the long-time managing director of the Gesellschaft für Produktionshygiene und Sterilitätssicherung GmbH (GfPS), which is also based in Aachen. This step continues the generational change of ecm at a further central position and at the same time bundles several decades of experience in connection with testing and certification procedures in the medical device industry.
ecm is supported by highly qualified and motivated internal and external staff. They do not only meet the regulatory qualification requirements, but also have a wide range of experience in industrial practice, university research and teaching, and the clinical use of products.