Monica Patti

m.pattinoSpam@axxos.noSpamch

  • PhD in Human Physiology, Thesis in Biophysics, University of Zurich
  • MSc in Neuroscience, Università di Trieste
  • Training and basic experience: ISO 13485, ISO 14971

 

Clinical Evaluation Specialist at Axxos GmbH since April 2018 

    Experience

    • 2 years biotechnology industry
    • 4 years research experience at University of Zurich and Tohoku University, Japan
    • Regulatory documents according to FDA requirement for Investigational New Drug (IND) application
    • Clinical evaluation reports according to MEDDEV 2.7.1 Revision 4

    Projects

    • Set up quality management systems as a part of the CE certification process for medical devices
    • Successfully drafting, reviewing and assembly Pre-IND and IND documentation for FDA
    • Publication of several scientific articles

    Skills

    • Review of regulatory documents to ensure completeness, accuracy and compliance with the FDA requirement
    • Writing and reviewing of scientific documents, papers and reports
    • Systematic scientific literature search, evaluation of literature
    • Holding nationally and internationally presentations
    • Knowledge of the Japanese culture and basics in Japanese language  

    My personal scrabble