Medical Devices

Medical Devices are important health devices, which encompass a wide range of products. They are intended by their manufacturer to be used for purposes common to medicinal products, such as preventing, diagnosing or treating human diseases. They must achieve their ends through mechanisms that do not translate into pharmacological, metabolic or immunological actions, so they are distinguished from medicinal products.

• Support in classifying medical devices
• Preparation/review of labelling and instructions for use
• Medical device registration/notification
• ANF registration
• Instruction of the processes for obtaining the CE mark
• Review of promotional material
• Surveillance
• Support in the development and maintenance of the quality management system
• Support to the technical manager