IVD and MDSW Expert
ACT-IVD, Alberta, Canada
Dr. Kenneth Fuh is a subject matter expert for the assessment of medical devices and in vitro diagnostic devices according to EU Regulation 2017/745 (MDR) and 2017/746 (IVDR). He has experience as a Product Assessment Expert for an EU Notified Body, with direct responsibility for the assessment of IVDs, medical device software, AI/ML-enabled medical devices, and cybersecurity aspects to meet the intents and requirements of the IVDR. In addition to a strong background in regulatory compliance for IVDs 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 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 a member of several professional associations including RAPS, the Canadian Association of Professionals in Regulatory Affairs, Chartered Quality Institute (Practitioner), Canadian College of Health Leaders, and the Clinical and Laboratory Standards Institute. He has also served on a standards committee for the Clinical and Laboratory Standards Institute and the Standards Council of Canada.
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.
Wednesday, April 23, 2025
2:15 PM – 3:15 PM East Coast USA Time