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