We clear the way to Compliance
Having supported several medical device manufacturers, we meet the Directive requirements for CE-marking, granting market access into the European Union.
Due to our contact with Notified Bodies, we understand their requirements and processes and thus, we are able to plan and implement appropriate regulatory strategies. Because of this knowledge, we are able to act efficiently to accelerate the market access of your products.
CE-marking – in compliance with EU directives 93/42/EEC for medical devices and 90/355/EEC for active implants allows broad access for your product to the EU and EFTA countries. In addition to that, CE-marking (based on a solid Technical Documentation) provides a basis for registration in various countries outside the European Union.
Our services include:
- Product classification and selection of suitable procedures for product conformity assessments
- Compilation of Technical Documentation
- Compliance check with Essential Requirements
- Selection of Test Laboratories, 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