mdc medical device certification GmbH

mdc medical device certification GmbH

Short description

Notified body in the field of medical devices and in-vitro diagnostics and accredited certification body for QM systems and prequalifications

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Range of products

  • S Certification

About us

For over 25 years, mdc has stood for safety and quality in the sensitive area of medical devices and healthcare.

More than 150 employees and almost as many external auditors, inspectors and technical experts currently contribute to this. They ensure that, as a notified body in the field of medical devices and in-vitro diagnostics and as an accredited certification body for QM systems and pre-qualifications, we are one of the leading providers not only in Germany but also in Europe. The comprehensive expertise of our employees enables us to offer certifications for a wide range of products and services and for companies of all sizes.

Even after more than 25 years in the assessment business, we are still eager to help you fulfil the requirements of regulations and standards.

When mdc was founded in 1994, we were one of the first Notified Bodies in Germany to be recognised in accordance with the European Medical Device Directive 93/42/EEC and were therefore able to operate in the field of CE marking of medical devices.  From the very beginning, we have earned our good reputation through comprehensive, professional and service-orientated customer support. We have continuously expanded our range of services and have continued to focus on our core competence of medical devices,

in vitro diagnostics and related areas. In addition to the constant expansion of our portfolio, the merger with the ZDH-ZERT e. V. certification body for medical devices in 2000 was a milestone in our history. This merger formed the basis for continuous growth.

With our branches in Stuttgart, Berlin, Tuttlingen, Vienna and Haifa, we emphasise our commitment as a competent local partner for our customers. More than 3000 customers in Germany, Austria, Israel and around 30 other countries rely on our expertise and service. Their customers and contractual partners rely on our certificates, attestations and products that bear the CE mark in conjunction with our identification number "0483". With our work, we not only make an important contribution to the safety of patients and users of medical devices, but also sustainably promote the concept of quality in the economy.

We are open to new solutions and see ourselves as your reliable service provider for the careful and objective assessment of your quality management system and your products!