EU

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
  • Identifying applicable essential requirements
  • Identifying 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 a 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.n, etc.

Contact me for further information
Nils-Åke Lindberg
Office +46 46 286 88 90 or send me an e-mail