mdc medical device certification GmbH

Endorse Company
Company Profile The Notified Body 0483 In 1994 mdc was notified by the German Ministry of Health (Bundesministerium für Gesundheit) to the European Commission for conformity assessment procedures under the European Medical Device Directive 93/42/EEC as one of the first German entities. The Commission assigned us the identification number 0483 and listed mdc as Notified Body in the official journal. mdc is not a newcomer in the medical device business. Being a foundation of Dr. Müller-Lierheim GmbH, to which mdc belonged until 1998, mdc could build on a good experience from technical and scientific services to the medical device industry. Since 2000-10-01 mdc medical device certification GmbH and Zertifizierungsstelle Medizinprodukte von ZDH-ZERT offer their services together under the name of mdc medical device certification GmbH – ein Unternehmen von ZDH-ZERT. ZDH-ZERT e. V. has been founded in 1994 as registrar for ISO 9001/2/3. In 1995 the Notified Body Zertifizierungsstelle Medizinprodukte von ZDH-ZERT e. V., which got the identification number 0538 under the MDD, has been founded. In the past ZDH-ZERT concentrated mainly on the certification small and middle-sized companies, especially in the field of health services and surgical instruments. mdc’s accreditation scope contains medical devices according to MDD 93/42/EEC and in vitro diagnostic devices according to IVDD 98/79/EC. This means that mdc is one of the few Notified Bodies in Germany which can offer the manufacturers of medical devices and in vitro diagnostic devices the necessary certifications for the European market. mdc’s success is based on synergy and co-operation. A worldwide network of co-operation partners and most of all a high number of lead auditors and technical experts with preclinical, clinical, technical and management background in medical devices warrant the effective, high level service our clients can rely on. mdc shares resources with other Notified Bodies and ISO 9000 registrars and contributes actively to the exchange of experience and information on a national and international basis. Moreover mdc’s experts serve in international and European standards committees and working groups of the EU Commission. The Governing Board defining mdc’s certification policy within the legal framework represents manufacturers, health professionals and test laboratories and certification bodies. We are proud that within a short time the marking CE 0483 on medical devices - indicating our involvement as Notified Body - has contributed to the international reputation of our clients and their products. In the meantime, due to the competent performance we offer, mdc belongs to the group of Notified Bodies that have achieved a globally known name together with a high reputation. Here mdc enjoys the flexibility of a private company that is necessary to react to the needs of our customers. mdc understands its task as a Notified Body to serve the public health as well as the medical device industry. We are accredited as Notified Body for conformity assessment procedures under Directive 93/42/ECC and 98/79/EC. Furthermore we hold an accreditation by ZLG the 'Central Authority of the States for Health Protection with Medical Devices' (Zentralstelle der Länder für Gesundheitsschutz bei Medizinprodukten) according to EN 45012 to certify quality systems in accordance with EN ISO 13485 in the field of all medical devices and in vitro diagnostic devices.