Dr Heike Vonhausen
Consultant Clinical Research Medical Devices


Services include 


  • Consulting service for conducting a Clinical Investigation or Post-CE Mark Study in Germany and/or Austria - find the best strategy in alignment with processes and timelines
  • Conducting submissions and obtaining approvals from German and Austrian Competent Authority (BfArM/BASG) and Ethics Committees
  • Conducting submission and obtaining approvals from the German Radiation Agency (Bundesamt für Strahlenschutz)
  • Assist in Clinical Investigational Plan (Protocol) development
  • Patient Informed Consent development and review
  • Assist in site selection and site assessment
  • Development of guidelines, procedure