Service

mdc medical device certification GmbH

Kriegerstr. 6 , 70191 Stuttgart
Germany

Telephone +49 711 253597-0
Fax +49 711 253597-10
mdc@mdc-ce.de

This company is co-exhibitor of
Baden-Württemberg International - Gesellschaft für int. wirtschaftl. u. wissenschaftl. Zusammenarbeit mbH

Trade fair hall

  • Hall 15 / G23
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 15): stand G23

Fairground map

MEDICA 2016 fairground map: Hall 15

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Technical equipment management, Test houses / Certification Bodies, Certification and testing of medical devices, quality assurance

Services

The application and technology of medical devices encompasses a broad spectrum and undergoes dynamic developments. Medical devices improve quality of life and even save lives. 

Specific legislation, as well as various quality standards, have been developed in order to ensure the devices’ safety and performance, which are essential for patients and users.  This is due to the fact that patients relying on the products often cannot make their own choice. A high level of expertise is required not only from manufacturers and their respective subcontractors and service providers, but from the certification bodies as well.

For legal manufacturers of medical devices we offer conformity assessment procedures according to Directive 93/42/EEC as a Notified Body (EU identification number „0483“). Conformity assessment with the involvement of a Notified Body is mandatory for all manufacturers of medical device products with the exception of class I (non-sterile, no measuring function). Our main activities involve not only on-site audits of a manufacturer’s quality system and associated subcontractors, but the assessment of Technical Files of the respective products as well.  For these activities we provide both trained auditors and a range of experts whom possess years of experience from industry, testing laboratories, hospitals, and Notified Bodies.

The demand for a voluntary certification, according to QM standards, has increased during the last several years. This holds especially true for suppliers of components, semi-finished products, as well as for subcontractors and service providers for the medical device industry.  A certificate according to EN ISO 13485, issued by a registrar which is recognized as a Notified Body, is a real benefit.  Usually manufactures consider the availability of a certificate according to EN ISO 13485 as evident, and the frequency of supplier audits are significantly decreased by the manufacturers’ Notified Bodies. In parallel with EN ISO 13485 the compliance with specific technical standards (e. g. validation standards for sterilization procedures) may be confirmed.

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About us

Company details

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.

 

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