Christiane Reinwald
Consultant Regulatory & Clinical Affairs at 4BetterDevices GmbH- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Experience
-
4BetterDevices
-
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
-
-
-
be-on-Quality GmbH
-
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
-
-
-
FAU Erlangen-Nürnberg
-
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”
-
-
-
SLK Kliniken Heilbronn Klinikum Am Gesundbrunnen
-
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 -
Friedrich-Alexander-Universität Erlangen-Nürnberg
Bachelor of Science - BS, Molecular Life Science