DEKRA Certification ISO 13485-Medical Device Quality Management System

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 recognized by the FDA and Health Canada. For an overview of our recognitions and scope, click here.

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

  • You’re allocated your own Project Manager
  • We’re a one-stop shop (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’re experts in complex regulatory and technical projects and 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.

To view other available medical services click here!

Get an ISO 50001 Certification Quote