Kyun Thibaut


  • Design and Development of innovatie medical devices (up to class III, active implantable).
  • Industrialisation and production (ISO 5-7 cleanrooms).
  • Verification and validation.
  • Clinical evaluation.
  • Set up and management of a QMS (ISO 13485).
  • Establishment of regulatory pathway and strategy (EU and US).
  • Realisation of technical files.
  • Management of suppliers & subcontractors.
  • Management of program budget and planning.
  • Resources allocation management.
  • Delivery management.
  • Exploitation management (exit strategy, valorisation).