think global from day one


about CE

The CE mark indicates the products compliance with EU directives regarding performance, quality and safety. It enables the commercialization of your product in 32 European countries. CE literally means “European Conformity”.

In case your app is a medical device we will handle the following.

First of all, to determine the adequate EU directive and classification of the app.

Then to prepare the technical file, meaning all product specific documentation, and a declaration of conformity which states that the medical device complies with the appropriate directive.

In case the medical device is a class II product, the manufacturer requires the certification of a quality management system (preferable ISO 13485).