As a Notified Body with the identification number 0124 we monitor conformity assessment procedures for medical devices according to MDD 93/42/EEC for companies which place medical devices on the market. Additionally as a certification body we certify quality management systems according to EN ISO 13485 for companies involved in manufacturing, distribution and all parts of the medical device delivery chain.
Your internationally recognized certified quality management system secures you approval for the European market. If you want to distribute your devices in other markets worldwide, other companies in the DEKRA Certification Group can cover all your transnational testing and auditing needs e.g. U.S.A., Canada, Brazil, Japan, Taiwan, Israel and Australia.
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