Achieve Success with European Medical Device Commercialization

Whether you are a US company bringing your medical device to market in the European Union, or an EU company commercializing a new product, the regulatory route for medical device approval in the European Union is very manageable – given the right knowledge and tools.

In this paper you will learn about:

• EU Medical Device Classification
• Required documentation for commercialization
• Tips on choosing a Notified Body
• The importance of Risk Management and Safety Testing