Martin Neumann
Senior Consultant @infoteam Software AG
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WORK HISTORY
Senior Consultant @infoteam Software AG
EDUCATION
TÜV SÜD Akademie
Industrial Cybersecurity Level 1 (Foundation) nach IEC 62443, Cybersecurity
HAN University of Applied Sciences
Bachelor of Applied Science - BASc, Carcinogenesis, Virology, Molecular Diagnostics
University of Lübeck and Technical University Lübeck
Regulatory Affairs Manager, Regulatory Affairs: Regulatorische Anforderungen an Medizinprodukte
Ruhr University Bochum
Master of Science (M.Sc.), Cell Biology, Biochemistry, Virology, Biotechnology
Bonn-Rhein-Sieg University of Applied Sciences
Bachelor of Science (B.Sc.), Applied Biology
University of Düsseldorf
Dr. rer. nat., Biology/ Biomedical Sciences
ABOUT MARTIN NEUMANN
Legal requirements must be complied with throughout the life cycle of medical devices and in-vitro diagnostics. Above all, safety and performance. The MDR / IVDR demands this central aspect and the implementation can be based on the application of and compliance with standards.I support you and your company in the implementation of these standards and the requirements of the MDR / IVDR.You would like advice or training on the subject- deep understanding of EU-MDR, EU-IVDR- deep understanding of Risk management (ISO 14971: 2019)- deep understanding of Cyber Security (IEC 81•••51, AAMI TIR57, Threat modeling, CVSS)- basic knowledge in QMS and ISMS and integrational Management Systems (ISO 13485 and ISO 27001)- deep understanding of medical Software Development (IEC 62304, IEC 82304-2)- good knowledge on EU AI-Act and relevance for medical devices as Well as AI-relevant standards in context of medical devices (e.g. AAMI TIR 34971)Just contact me here at LinkedIn
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