Medical devices

Testing and certifiying medical devices

Results through knowledge, flexibility and decisiveness

International rules for certification and approval marks are extremely complex. We can help you adopt the smartest certification approach in order to ensure that your products are issued with marks in your target markets as quickly, efficiently and cost-effectively as possible.

With DEKRA certification, you effectively get one-stop access to global markets. Basically, you don’t need to deal with all this complexity. If you tell us which countries you wish to target, we will tailor our certification procedures to the requirements of those countries. Our dedicated staff – who are all experts in regulations worldwide – are spread across our global network of offices. They can help you make applications in most countries in the world.

Below you will find an overview of our most important services in this area.

European market access


Your Notified Body for AIMDD, MDD, IVD, animal tissue directive and blood directive. Check out our full scope here.

Worldwide market access


Third party services for access to important medical markets, e.g. Canada, USA, Taiwan, Japan, Australia and Brasil.

Management System Certification


Certainty in quality and safety: International quality system certification according to ISO 13485, ISO 9001 and ISO 14001.

Custom made services


Guidance Regulatory Pathway Review, Clinical Protocol Review and training: We help you reduce risk and shorten time to market.

News & events


Stay up-to-date with developments at DEKRA: an overview of latest news, press releases and events where you can meet us in person.

Why DEKRA


As your Notified Body, we're a reliable, flexible, responsible partner. 5 reasons to choose for DEKRA.