DR. BAAL MedDev Consultant

Clinical Research with Medical Devices

Services

  • Clinical Investigational Plan (Protocol) development
  • Patient Informed Consent development and review
  • Site Assessment
  • Ethics Committee dossier preparation, submission, progress tracking
  • Competent Authority dossier preparation, submission, progress tracking
  • Investigational site initiation and training
  • Provide technical support for investigational device usage during study procedures
  • Development of guidelines, procedures
  • Quality assurance measures, such as co-monitoring visits and review of reports
  • Author publications and reports
  • Authorized Representative for companies outside EU
  • CRO selection for Medical Device Clinical Investigations
  • Translation services