You’re in the driver’s seat
As a market leader worldwide in CE certification, DEKRA offers you more than reviewing technical files, design dossiers, or Quality Management systems. With numerous tools we are able to guide you to do it right from the start, helping to accelerate CE approval. Moreover, we open up the world for your devices with our market access services to all mayor countries.

We show you the way, but we'll never take the wheel from your hands. With DEKRA you remain in control, while we guide you to find the most promising directions for your particular demands, always being in line with the latest regulatory requirements.

Two Bodies became one
As you may know, DEKRA and the former KEMA Quality have recently joint forces. As a Notified Body, DEKRA is fully accredited for the certification of medical devices. You'll continue to benefit from the services you're used to receiving from the former KEMA Quality. But you'll also get new opportunities, like the use of the chemical laboratories at DEKRA, or the extended market access services of the former KEMA Quality. With over 150 Medtech/IVD experts who have joint forces in one globally acting team we can give you a lot more personal guidance, flexibility and expertise.

When quality drives your business
But there's more. Our first and most important goal is to safeguard quality in your products and processes, and this is and will be an important strategic strengh for you, giving you a real advantage over the competition.

Your personal guide
At DEKRA you are allocated to a dedicated project team. Project manager and back office employee are your contact for all our services. Our project managers have a background in the medical device or IVD industry, mostly in R&D and/or manufacturing. They speak your language, understand your challenges, are dedicated to guide and to discussing solutions for compliance problems.

Your project manager knows your company, your market, your clients, your quality system, and your devices. He or she is responsible for answering all of your questions, arranging and participating in audits, assuring competent reviews of your submissions and providing clear quotations for additional services. All in a personal way, making the road to certification as smooth and efficient as possible.

Contact your personal guide