Prof. Dr. Stephen Gilbert

Pic of Prof. Dr. Stephen Gilbert

Head of the Group Medical Device Regulatory Science, Else-Kröner-Fresenius Center of Digital Health, Technical University Dresden

Role in LiSyM-Cancer

  • Partner in DEEP-HCC
  • Support and mentoring for LiSyM-Cancer on the quality requirements for medical devices, IVDR requirements and the AI Act
  • Scanning of the LiSyM Cancer Implementation and Approval Landscape
  • Prioritization of projects based on the LiSyM cancer implementation and approval
  • Development of a regulatory strategy for the prioritized LiSyM cancer implementation projects

Expertise

  • Medical Device Regulatory and Certification policy and strategy expert
  • Regulatory requirements, especially for software as a medical device and artificial intelligence in medical devices
  • Innovative approaches to regulation of healthcare of the future

Degrees

  • 2005–2008 Doctor of Philosophy (Ph.D.), Computational Biology University of Leeds Professional Experience
  • Since 2022 Head of Medical Device Regulatory Science, Else-Kröner-Fresenius Center of Digital Health, Technical University Dresden
  • 2019 – 2022 Clinical Evaluation Director, Ada Health, Berlin, Germany
  • 2017 – 2019 Manager - Clinical Evaluation/Regulatory Affairs team at BIOTRONIK SE & Co. KG, Clinical Evaluation/Regulatory Affairs team at BIOTRONIK SE & Co. KG
  • 2014 – 2017 Senior Post-doctoral Research, Max Delbrück Center for Molecular Medicine Berlin, Germany
  • 2012– 2014 Independent Post-doctoral Research Scientist, L'Institut de Rythmologie et Modélisation Cardiaque, Bordeaux Area, France
  • 2008 - 2012 Senior Independent Research Fellow, University of Leeds