Christiane Reinwald

Consultant Regulatory & Clinical Affairs at 4BetterDevices GmbH
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Contact Information
us****@****om
(386) 825-5501
Location
Erlangen, Bavaria, Germany, DE

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Experience

    • Germany
    • Business Consulting and Services
    • 1 - 100 Employee
    • Consultant Regulatory & Clinical Affairs
      • Apr 2020 - Present

      Clinical Evaluation (MDR 2017/745)Performance Evaluation (IVDR 2017/746)Biological Evaluation (ISO 10993, ISO 18562)Summary of safety and clinical performance including layman partPost-Market Clinical Follow UpPost-Market SurveillanceMDR-Gap AnalysisWorkshops on Clinical & Biological Evaluations Clinical Evaluation (MDR 2017/745)Performance Evaluation (IVDR 2017/746)Biological Evaluation (ISO 10993, ISO 18562)Summary of safety and clinical performance including layman partPost-Market Clinical Follow UpPost-Market SurveillanceMDR-Gap AnalysisWorkshops on Clinical & Biological Evaluations

    • Germany
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Consultant Regulatory Affairs and Quality Management
      • May 2019 - Mar 2020

      Clinical Evaluation (MDR 2017/745)Performance Evaluation (IVDR 2017/746)Biological Evaluation (ISO 10993)Audit (ISO13485, FDA Mock Audit)MDR-Gap AnalysisWorkshops on Clinical Evaluations Clinical Evaluation (MDR 2017/745)Performance Evaluation (IVDR 2017/746)Biological Evaluation (ISO 10993)Audit (ISO13485, FDA Mock Audit)MDR-Gap AnalysisWorkshops on Clinical Evaluations

    • Researcher PHD Student
      • Sep 2014 - Feb 2019

      Scientific writingSupervisor of medical PhD students and Master studentsSelf-reliant planning of experiments, statistical analysis of collected data and the subsequent presentation at conferences or seminars Scientific writingSupervisor of medical PhD students and Master studentsSelf-reliant planning of experiments, statistical analysis of collected data and the subsequent presentation at conferences or seminars

    • Germany
    • Research Services
    • 700 & Above Employee
    • Scientific Assistant
      • Jul 2013 - Sep 2013

      Supervision of the Master module of Biology “Pathogenicity factors of Gram positive bacteria” Supervision of the Master module of Biology “Pathogenicity factors of Gram positive bacteria”

    • Germany
    • Medical Practices
    • 1 - 100 Employee
    • Intern Student
      • Apr 2009 - Oct 2009

      Departments: Dermatology, Gastroenterology, Cardiology, laboratory diagnostics and blood bankHealthcare Infectious diseases and its treatmentsOperation procedures and techniquesIn vitro diagnostic methods Departments: Dermatology, Gastroenterology, Cardiology, laboratory diagnostics and blood bankHealthcare Infectious diseases and its treatmentsOperation procedures and techniquesIn vitro diagnostic methods

Education

  • Friedrich-Alexander-Universität Erlangen-Nürnberg
    Master of Science - MS
    2012 - 2014
  • Friedrich-Alexander-Universität Erlangen-Nürnberg
    Bachelor of Science - BS, Molecular Life Science
    2009 - 2012

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