Biogecho has a well-established presence in the EU, with offices in Switzerland and in France. We have assisted several medical device manufacturers with compliance in Europe.
Our services include:
- Assistance with product classification and identification of applicable standards for your medical devices
- Medical device CE Marking Technical File / Design Dossier compilation and review
- Verification of Essential Requirements
- Preparation, implementation, modification and maintenance of a Quality Management System (ISO 13485) that will meet European and other international requirements
- Authorized Representative services in Europe
- Risk assessment and management (ISO 14971)
- Development of vigilance and post-market surveillance procedures