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 medicines, such as preventing, diagnosing or treating a human disease. They must achieve their ends through mechanisms that do not translate into pharmacological, metabolic or immunological actions, so they are distinguished from medicines.
- Preparation of technical dossiers
- Elaboration of expert reports
- Preparation of documentation to request conformity assessment of active, non-active and in vitro diagnostic medical devices
- Procedures for obtaining the CE conformity marking