Regulatory Certification of Medical and Healthcare Devices Based on Regulatory Science for Global Compliance
Ryuji Kohno, Ph.D., Professor, IEEE and IEICE Fellows Director, Medical ICT Center, Yokohama National University, Japan Distinguished Professor, Centre for Wireless Communications, University of Oulu, Finland
Abstract: Procedure of regulatory compliance testing healthcare devices as well as medical devices should be analytical and quicker for social service and business. Regulatory science is an interdisciplinary subject between natural and social sciences because its aim is making a regulation for social wellness and services which can be acceptable under logical argument by all stakeholders while an approach of determining technical requirement for the regulation should be analytical using numerical evaluation of benefit versus risk of the employed technologies and the applied services in focused use cases such as regulatory compliance of medical and healthcare devices. This talk will address compliance testing "Class 0.5 device," which is defined as a healthcare device with lower risk than class 1 medical device, in order to promote global business of uncertificated healthcare devices.
Ryuji Kohno received the Ph.D. degree in electrical engineering from the Univ. of Tokyo in 1984. Since 1998 he has been a Professor of Division of Physics, Electrical and Computer Engineering and a director of Medical ICT Center in Yokohama National University in Japan. During 1984-1985 he was a Visiting Scientist in Dept.EE, Univ. of Toronto. Since 2007, he is also a Finnish Distinguished Professor in Univ. of Oulu, Finland. Moreover, he was also a director of SONY ATL during 1998-2002 and was a director of the UWB Tech. Inst. and Medical ICT Inst. of National Institute of Information and Communications Technology (NICT) in Japan. He was elected to be a BoG member of the IEEE Information Theory Society three times on 2000, 2002, and 2006. He was an editor of the IEEE Trans. Information Theory during 1995-1998, that of the IEEE Trans. Communications during 1994-2002 and that of the IEEE Trans. ITS during 2000-2006. He was a vice-president of Engineering Sciences Society of IEICE, and an editor-in chief of the IEICE Trans. Fundamentals. He is also a founder and International Steering Committee chair of series of both ISSSTA and ISMICT.
Genetic Testing: Keep it simple. Keep it actionable
Ana Teresa Freitas, CEO, HeartGenetics, Genetics and Biotecnology SA, Portugal, Professor, Instituto Superior Técnico, Portugal
Abstract: HeartGenetics is a Portuguese startup company in the business of developing new certified high-tech software that makes genetic data actionable and integrated with the medical doctors knowledge. Heartgenetics is bridging the gap between the medical doctors need for genetic report to talk about risk, medical guidelines and therapeutics and the healthcare industry needs for new devices that are cost-effective, simple-to–use and that automatically produce this type of personalized knowledge.
This talk will be about the current challenges of genetic testing, data analysis and at the ultimate end about a more personalized medicine or life style recommendations.
Ana Teresa Freitas (PhD) is CEO and co-founder/shareholder of HeartGenetics, Genetics and Biotechnology SA, since 2013. HeartGenetics is a Portuguese startup company, spin-off of Instituto Superior Técnico, developing new certified medical devices (software and machine learning tools and genetic tests kits) that make genetic testing actionable and cost-effective. She holds a PhD in Computer Engineering (2002) and a Master degree in Electronics Engineering. She has diploma of the Advanced Management Program on Innovation and Entrepreneurship from Católica Lisbon – BES, School of Business and Economics (2013). Her main expertise is on the areas of Computational Biology, Human genetics, Algorithms and Data Mining. As a Full Professor at IST, University of Lisbon, Department of Computer Science and Engineering, she developed the Computational Biology field.