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Kenneth Fuh, PhD

Product Assessment Expert
TÜV SÜD GmbH, Canada

Dr. Kenneth Fuh is an IVD Product Assessment Expert at TÜV SÜD GmbH. In this role, he is responsible for assessment of technical documentation of in vitro diagnostic medical devices. Dr. Fuh is a CQI/IRCA-certified ISO 13485 and ISO 9001 Lead Auditor and a Senior Product Specialist for the assessment of medical device software and AI-enabled medical devices to meet the intents and requirements of EU Regulation 2017/745 (MDR) and 2017/746 (IVDR). He holds several certifications including Technical Documentation according to the IVDR, Risk Management for Medical Devices (ISO 14971), and Medical Device Software Life Cycle Processes (ISO 62304). Dr. Fuh is a SAS-certified machine learning expert and a member of several professional associations including The Canadian Association of Professionals in Regulatory Affairs, Chartered Quality Institute (Practitioner), Canadian College of Health Leaders, and the Clinical and Laboratory Standards Institute.

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