Medical Devices
Media Kompass is ready to help you determine the best regulatory affairs strategy for managing medical devices requirements in the European Union (EU).
As a medical device company, you have certain obligations set out by European regulations as well as local authorities.
-
Preparation of documentation for the approval of import / distribution of medical devices
-
Preparation of documentation for approval of service / maintenance activities for medical devices
-
Ensuring the personnel needed for conformity person
-
Vigilance for medical devices
-
Advertising for MD materials – evaluation of conformity/ elaboration
-
Manufacturer registration, authorized representatives of medical devices
-
Registration of medical devices in the national database of medical devices
-
Regulatory affairs
-
EU Authorized Representative
-
Record of economic operators in Eudamed
-
Post-market monitoring plan
-
PSUR
-
PMCF – Post-market clinical follow-up