Medical Devices and in vitro diagnostic tests must have a CE Mark before you can place them on the market. This includes digital health products and Apps, if they meet the definitions in the regulations.
We will advise you whether your product requires a CE Mark or not. If it does, we will help you with device classification and routes to compliance with the relevant European Directive.
We will help you compile your Technical File and if you haven’t got them already help prepare and implement the Quality Management Systems and Procedures demanded by the regulatory authorities to demonstrate compliance.
We support you through the process of obtaining a CE Mark for your medical device or in vitro diagnostic device where this is required.
So, if you are unclear about your regulatory obligations, why not drop us a line for a free consultation.
Full details on our Contact page