Dr. Silvia Georges leads the team responsible for clinical affairs and the biological safety of medical devices at NSF. She has over six years of experience in regulatory affairs for basic animal research and pharma, followed by four years in medical devices.
Silvia obtained her diploma in biology from the University of Tübingen in Germany and her Ph.D. in neuroscience from the Graduate Training Centre of Neuroscience and the Max Planck Institute for Biological Cybernetics in Tübingen, Germany. She completed further training programs to broaden her expertise and meet clients’ needs.
Silvia expanded NSF’s service offering with biological evaluations of medical devices in accordance with ISO 10993 and ISO 18562. Aside from biological safety, Silvia has a wide range of experience in clinical evaluations according to Regulation (EU) 2017/745 and MEDDEV 2.7/1 rev. 4, as well as in clinical investigation according to ISO 14155. She also provides biostatistical and data analysis support to these projects.
Silvia shares her expertise in several extremely popular articles and seminars, including:
- ISO 10993-23: The “Step-Wise” Approach to Evaluate Potential Irritants in Medical Devices Becomes Effective
- Biological Evaluation of Medical Devices — Assessment of Biocompatibility Under ISO 10993-1:2018
Areas of Expertise:
- Biological Evaluation of Medical Devices
- Clinical Affairs
- Medical Writing
- Training Instructor