mdc medical device certification GmbH of Stuttgart at MEDICA 2017 in Düsseldorf -- MEDICA - World Forum for Medicine
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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 GmbH Gesellschaft für int. wirtschaftl. u. wissenschaftl. Zusammenarbeit

Hall map

MEDICA 2017 hall map (Hall 15): stand F23

Fairground map

MEDICA 2017 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

CE Marking

In the area of CE marking we cover a wide range of devices under Directives 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostic devices.

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

QM Certification

Various quality system standards are the basis for our certification services. Besides EN ISO 9001, which covers a wide scope of activities in all areas, we offer certification according to EN ISO 13485, which is specifically intended to be used in the field of medical devices. Manufacturers of primary packaging materials or primary packaging components for pharmaceuticals can be certified according to EN ISO 15378.

We are one of the few European Notified Bodies, whose audits of medical device manufacturers based in Europe, are recognized under the Technical Cooperation Program (TCP) in Taiwan. Audits for medical device companies seeking approval in Canada of Japan can be offered in cooperation with locally-recognized registrars.

Furthermore, we offer assessment and certification of health care institutions, doctors‘ offices and providers of other health care supplies according to special German requirements.

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

Medical Devices

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.

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

In Vitro Diagnostic Devices

A special group of medical devices are in vitro diagnostic devices. Even though they are not applied directly on the human body, in vitro diagnostics have a high potential of risk due to their critical intended use and high-volume use for examinations. Manufacturers, suppliers and service providers are subject to high quality requirements, which also demand a technical competence from the conformity assessment bodies.

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

Pharmaceuticals

For pharmaceutical companies and their suppliers, there is a full set of legal requirements to be installed and maintained within the framework of a quality system. There are extensive obligations for the pharmaceutical manufacturers regarding supplier control, which may be supported by respective certification systems.

Many suppliers to the pharmaceutical industry use the worldwide recognized standard EN ISO 9001 as a basis for their quality system, which may be amended accordingly if there are special requirements regarding their products or services.

Suppliers of primary packaging materials can use EN ISO 15378 as a quality standard, which contains GMP requirements specifically for this sector in addition to ISO 9001 requirements. We are one of the few registrars in Europe which are accredited for this standard.

Some medical devices are, with respect to their characteristics and manufacturing technology, similar to pharmaceutical products. Therefore a significant number of pharmaceutical companies also function as medical device manufacturers or subcontractors for production of medical devices. In such cases the full range of certification services applicable for medical devices, such as Directive 93/42/EEC, EN ISO 13485 or EN ISO 9001 may be used by pharmaceutical companies.

Amongst our auditors and experts we have a range of skilled persons experienced in the pharmaceutical sector and, therefore, particularly qualified to perform audits in this specific area.

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About us

Company details

”mdc medical device certification“ stands for safety and quality in the sensitive field of medical devices and healthcare.

Our experienced staff of more than 60 employees and 70 external auditors and experts ensure knowledge and experience in the relevant key technologies of medical device manufacturing and testing. Due to their contributions we not only belong to the major Notified Bodies for medical devices and in-vitro diagnostic devices in Germany, but throughout Europe and to the major quality system registrars in our sector. The comprehensive knowledge of our staff enables us to offer certification of a wide range of products and of companies of all sizes.

More than 2000 clients in more than 30 countries rely on our knowledge and our services. Their clients and business partners also rely on our certificates and the devices, which are CE marked in combination with our identification number “0483”.

Our activity is an important contribution to safety of patients and users of medical devices and should, in addition, encourage the awareness for quality in the enterprises.

Competence, independence, objectivity, neutrality and confidentiality are the cornerstones of our activities.

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