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Certification of medical devices

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

The market for medical devices is characterized by fierce international competition, numerous regulations and constant change. Takeovers lead to shifts in the competitive situation, and innovative strength and speed are decisive for market success. In these changing times, it is equally important to focus on your strengths and specialize.

As a notified body with the identification number 0124, we are involved in the conformity assessment procedure for medical devices in accordance with Regulations (EU) 2017/745 and (EU) 2017/746 for companies that place medical devices on the market. As an accredited certification body, we also certify quality management systems in accordance with EN ISO 13485 in companies that manufacture or distribute medical devices or are part of the supply chain.
Downloads
Here you will find all downloads for medical devices!
Downloads