DR. BAAL MedDev Consultant

Clinical Research with Medical Devices

Professional Expertise

  • Conduct of Clinical Investigations according to ICH GCP and Medical Device Regulations (EN ISO 14155 , MEDDEV Guidelines, National Regulations) in various European countries
  • Dossier preparation and submission to Ethics Committees, Competent Authorities     
  • Medical writing: Clinical Investigational Plan (Protocol), Patient Informed Consent, Case Report Form, Reports, Publications, Guidelines, and Procedures     
  • Project management, development of study concepts in collaboration with Key Opinion Leaders, marketing and regulatory departments
  • Monitoring according to regulations, international quality standards and company SOPs
  • Languages: German native speaker, English – excellent verbal and written communication
  • Computer skills: MS-Office package

    --> Therapeutic Expertise