Dr Heike Vonhausen
Consultant Clinical Research Medical Devices


Professional Experience 

  • Development and conduct of training for Clinical Investigations, Medical Devices and regulatory aspects, in-house and for clinical research staff 
  • Conduct of Clinical Investigations according to Medical Device Regulations and EN ISO 14155 in various European countries 
  • Staff responsibility in an internationally operating medical device company, staffing of clinical projects according to milestones and quality standards, staff development and coaching  
  • Vendor selection for Medical Device Clinical Investigations, contract negotiations, contract management 
  • Project management, budgeting, development of study concepts in collaboration with Key Opinion Leaders, marketing and regulatory departments 
  • Dossier preparation and submission to Ethics Committees, Competent Authorities and other regulatory agencies (i.e.Bundesamt für Strahlenschutz) 
  • Medical writing: Clinical Investigational Plan (Protocol), Patient Informed Consent, Case Report Form, Reports and Publications, Guidelines, Procedures 
  • Monitoring according to regulations, international quality standards and company SOPs 
  • Languages: German native speaker, English – excellent verbal and written communication