Welcome to our Website

Medidee provides expertise in Regulatory Affairs for Medical Devices and assistance for Quality System Management (QMS) implementation. Our services cover all steps of a medical device development, from the initial project idea over the design & development to certification or regulatory clearance.

Based in Switzerland, we are active over all Europe and specialized in the compliance with European Directives covering medical products.We can also provide support for registering your product in the United States, in Canada, Australia or with Asian countries.

Additionally we can provide assistance in establishing a Quality Management System which complies with regulatory requirement and help with setting up the necessary clinical validations in order to gather the supporting data for a successful submission.

If you are looking for manufacturing partners, we would be happy to provide you with numerous qualified contacts and/or assisting you in the definition of your manufacturing process map.

For registered users, there is also our Resources section which provide extended information and material to facilitate your regulatory process.