The German Medical Device Act requires that the manufacturers of medical devices appoint a Safety Officer. This person is to take over the legally defined responsibilities within the established reporting system. The Safety Officer is expected to have a certain level of qualification.

Thanks to the wide range of staff qualification, MDSS can offer the service of an external safety officer for a large amount of product areas. Additionally, we have long-term experience  from our work as Safety Officer for our non-European clients (Authorized Representative).

Our consultancy covers the following areas:

•   - Risk assessment in cases of events
•   - Evaluation of complaints with regard to
  
•     reportability
•   - Correspondence with the Competent Authorities
•   - Monitoring/ Support with corrective actions and
  
•     recalls

If you would like to receive further information about this service please feel free to contact MDSS Consultancy via our contact form. We are looking forward to hearing from you.