Alexander Stock

Project Manager IVD Medical Device Testing at TÜV SÜD

Speaker

Dr. Alexander Stock is a quality management professional with 18 years of experience in the biomedical and IVD software industry within multi-national companies.

In his current position as a “Project Manager IVD Medical Device Testing” he is responsible for the expansion of the IVD medical device testing services at TÜV SÜD with the goal of helping customers to demonstrate compliance against various standards and to ensure product safety and effectiveness.

Prior to taking on this role, he served as lead auditor and product specialist (technical file assessments) for in vitro diagnostic medical devices under IVDD, IVDR, MDSAP, ISO 13485, ISO 9001 etc.

Also, Alexander contributed to the IVDR implementation and preparation for the designation of TÜV SÜD and accompanied clients on IVDR projects.

Alexander is member of RAPS US and RAPS Deutschland e.V. and participates in the RAPS EuroConvergence Conference Committee. Also, he is the chair of the TEAM NB (The European Association of Medical devices Notified Bodies) Taskforce Group “IVD Software” and presents regularly on international conferences about IVDR/MDR software/cybersecurity/AI topics.

Industry Sectors:

In Vitro Diagnostic Medical Devices/Medical Devices, Bioinformatics, Pharma/Biotech, Medical Imaging, Image Analysis, High-Content Screening/Data Mining, Digital Pathology, Immuno-Oncology Diagnostics.

Focus Areas:

IVDR, IVD Software, Medical Device Software, Cyber Security, Artificial Intelligence