We use cookies on our website to personalize content and ads, to provide social media features and to analyze traffic to our website. To provide you with a convenient online experience and to improve our communications, please click "ACCEPT ALL". By doing so, you consent to the processing and sharing of your information with our social media, advertising and analytics partners. You can revoke your consent at any time in the settings .
Data protection declaration | Legal notices
Setting

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)
  • Faster time to market
  • 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.

Our Services

Further services

  • Microbiology and Sterile Medical Devices
  • Mobile Devices
  • Ophthalmic Devices
  • Orthopedic and Dental Devices
  • Software
  • Vascular Devices
  • Wound Care