Your MDR and IVDr partner to CE registration - Your partner for FDA submissions - We deliver excellence

Medical Affairs

MARACA International offers a unique service as Medical Practitioner

This includes:

  • Physician input and review of the design of the product
  • Advisor in the development of Companion diagnostic products
  • Risk management review for patient impact
  • Health Hazard assessment of a complaint for patient impact
  • Risk-Benefit summary development and signing as Medical Practitioner
  • Clinical evidence development from literature review and signing as Medical Practitioner
  • Assessment of clinical evidence in the Performance evaluation report
  • Clinical performance study protocol development
  • On-market clinical study protocol development
  • Clinical performance study synopsis as Medical Practitioner
  • Statistical analysis plan with endpoints for clinical performance study
  • Clinical performance study report writing and signing as Medical Practitioner
  • Physician representation with FDA and competent authorities

With more than 20 years’ experience with these activities, we can provide you with unique service excellence. More detailed information and making a proposal?