.jpg "Kenneth Fuh, PhD photo")
Senior Product Specialist
TÜV SÜD Product Service GmbH, Canada
Dr. Kenneth Fuh is a Senior Product Specialist at TÜV SÜD Product Service GmbH Notified Body, with direct responsibility for the assessment of medical device software, AI/ML-enabled medical devices, and cybersecurity aspects to meet the intents and requirements of the MDR and IVDR. In addition to a strong background in regulatory compliance for medical devices and in vitro diagnostic medical devices in both domestic and international jurisdictions, Dr. Fuh is a CQI/IRCA-certified ISO 13485 Lead Auditor and has direct experience with 21 CFR part 820 and Health Canada regulations.
Dr. Fuh holds several certifications including Technical Documentation according to the MDR and IVDR, Risk Management for Medical Devices (ISO 14971), Medical Device Software Life Cycle Processes (ISO 62304 and ISO 82304-1) and Medical Device Cybersecurity Risk Management. He is a SAS-certified machine learning expert and has direct industry experience in leading the establishment and implementation of a strategy for the design, development, validation, clinical demonstration, and regulatory compliance of in vitro diagnostic assay systems incorporating AI/ML for cancer detection. Kenneth holds a Doctor of Philosophy Degree in Biomedical Engineering, a Master of Science in Biotechnology, and a Bachelor of Science in Biochemistry. He is also a certified Project Management and Lean Six Sigma Black Belt Professional, and first-author on several peer-reviewed scientific publications.
Artificial Intelligence – Medical Devices and IVD’s conformity Assessment and CE Marking
Thursday, September 19, 2024
3:15 PM – 4:15 PM PDT