For safety and quality.”
mdc medical device
certification GmbH
Since more than 25 years mdc stands for safety and quality in the sensitive field of medical devices and related areas.
More than 150 employees and about 70 external auditors and technical experts currently contribute. They ensure that we are one of the leading providers, as a notified body in the field of medical devices and in-vitro diagnostics and as an accredited certification body for QM systems 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 conformity assessment, we are still eager to learn about your way to fulfill the requirements of regulations and standards.
Our experience
MORE THAN 25 YEARS
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 certification body for medical devices of ZDH-ZERT e. V. in 2000 was a milestone in our history. This merger formed the basis for our further continuous growth.
Your reliable local partner
FIVE OFFICES WORLDWIDE
With our offices 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”. 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 companies.
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!
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