Notified body for medical devices

Independence and neutrality

DEKRA Certification GmbH is a notified body and certification body for medical devices.

As a Notified Body with the identification number 0124, DEKRA Certification GmbH accompanies conformity assessment procedures for medical devices in accordance with Directive 93/42/EEC, Regulations (EU) 2017/745 and (EU) 2017/746 for companies placing medical devices on the market. In addition, DEKRA Certification GmbH, as an accredited certification body, certifies quality management systems according to EN ISO 13485 in companies that manufacture or distribute medical devices or are part of the supply chain.

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