Medidee is ready to support you with following services:

  • on-site training of regulatory / quality teams
  • gap analysis specific to your product lines
  • strategic planning of your compliance program
  • coherence with ISO 13485:2016 changes

The key changes will be:

  • Merge of AIMD as class III medical devices
  • Deployment of UDI identification system
  • Stronger control on the economical operators (distributors, importers)
  • Scrutiny procedure for innovative products
  • Review of the validation plan for new devices by a central authority