EU
We provide support services for CE marking of medical devices and in vitro diagnostic devices according to EU directives and the new EU regulations: MDR 2017/745 and IVDR 2017/746
- CE marking support of all classes of medical devices and IVD devices
- Assessment of product qualification and classification. Borderline cases
- Selection of conformity assessment route
- Identifying applicable essential requirements and GSPR
- Identifying applicable harmonized standards and other standards
- Design control
- Risk management and software risk management
- Technical File and Technical Documentation, including STED
- Review and gap analysis of technical documentation for improvement
- Evaluation and selection of a suitable notified body
- Labeling compliance
- Quality management system
- Software compliance, new or legacy software
- Management of responses to questions from notified body or competent authorities
- National registration for Italy, France, Spain, etc.
Contact me for further information
Nils-Åke Lindberg
Office +46 8 621 01 05 or send me an e-mail