CE-marking support
We provide services for CE-marking of Medical Devices and In-vitro diagnostic devices.
- CE-marking of all classes of medical devices and IVD devices
- Assessment of product classification
- Selection of conformity assessment route
- Identification of applicable essential requirements
- Identification of applicable harmonized standards
- Design control
- Risk Management and Software Risk Management
- Technical file and documentation, including STED
- Review and Gap analysis of technical documentation for improvement
- Evaluation and selection of Notified Body
- Labeling compliance
- Quality management
- Software compliance, new or legacy software
- Management of responses to questions from Notified Body or competent authorities
- National registration, Italy, France, Spain, etc
Contact me for further information
Robert Ginsberg
Office +46 8 621 01 05 or send me a mail