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 46 286 88 90 or send me an e-mail