CE Marking
Our service
- Product classification and selection of suitable procedures for product conformity assessments
- Compilation of Technical Documentation
- Compliance check with Essential Requirements
- Selection of Notified Bodies and relevant coordination activities
- Definition and admission of combination products
- Support on market surveillance for your products and establishment of an appropriate vigilance system for your products
- Demarcation and identification of correct process for marketing authorization for borderline products
Special fields in which we are highly competitive due to our experience in the sector of drug marketing authorisation for many years
- Accomplishment of consultation procedures for medical devices
- Switch of drugs to medical devices
- CE Marking of drug-like medical devices
- Communication and coordination with drug authorities
- Development of therapy systems in cooperation with phamaceutical companies
