DEKRA Medical Services

Your Notified Body for certification worldwide

Manufacturers of medical devices and In-Vitro Diagnostics (IVD) devices require certificates in order to sell their products in markets around the world. You can call on DEKRA for product certification and certification of your quality management system according to ISO 13485.

When you choose DEKRA, you’re choosing more than just a certifier with an outstanding international reputation. We operate virtually everywhere in the world and our project managers have a background in the medical device or IVD industry, mostly in R&D and/or manufacturing. We participate in all the MRAs and are officially recognised by the FDA and Health Canada.

We are a reliable, flexible and responsible partner. And we understand your need to keep your time to market as short as possible. There are a number of other good reasons for choosing DEKRA:

  • You are allocated your own Project Manager
  • We are a full-service provider (combining CE certification with ISO 13485 audits, thus saving you considerable time and money)
  • Modular reviews, pre-approval of clinical protocols and regulatory pathways
  • We offer a fixed programme for Transfer of Certification

We are experts in complex regulatory and technical projects and are proud to be one of the five largest Notified Bodies in the world. The quality, knowledge and service of DEKRA are a benchmark in the medical industry.

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