team

Frank Stein

Guest Trainer

Qualifications

With a background in biomedical engineering and a passion for advancing healthcare technologies, I have built a career spanning over two decades as a consultant, senior trainer, and professor in the medical device industry. My work focuses on regulatory affairs, quality management, project management, and innovation in healthcare - helping organizations across the globe bring safer, more effective medical technologies to market. My journey began in academic research, where I contributed to the development of cardiology devices, tissue engineering applications, and implantable medical devices. This hands-on technical experience gave me a deep understanding of the complex relationship between technology, regulation, and patient safety. Over time, I expanded into consulting and education, specializing in helping companies navigate the evolving regulatory landscape, including MDR, MDSAP, ISO 13485, ISO 14971, ISO 19011, IEC 62304, and other international standards. As a senior trainer for international organizations such as the British Standards Institute, the German Institute for Standardization, and MetricStream, I have designed and delivered training programs across Europe, the US, and Central Asia. I also serve as a professor and lecturer at universities in Kyrgyzstan, Latvia, and Armenia, where I teach medical engineering, quality management, and project management while fostering research partnerships between academia and industry. Throughout my career, I have remained dedicated to knowledge-sharing, cross-border cooperation, and supporting the growth of professionals in the life sciences sector. My work has been recognized with an honorary doctorate for contributions to healthcare education and rehabilitation projects in Eastern Europe and the Middle East.

  • 2014.08 Professor for Medical Engineering, Quality- & Project Management, I. Arabaev Kyrgyz State University, Kyrgyzstan
  • 2013.12 Honorary Doctorate, Progress University of Gjumri, Armenia
  • 2000.03 – 2003.12 PhD in Physics, University of Canterbury, UK
  • 1994.09 – 1999.03 Biomedical Engineer (Dipl.-Ing. Biomedical Engineering)
  • University of Applied Science Aachen / Juelich, Germany
  • 1991.10 – 1994.06 Physics (Preliminary diploma)
  • RWTH Aachen, Germany
  • 1990.07 – 1991.09 Bundeswehr Army Officer School Germany
  • 1986.08 – 1990.06 Gymnasium Rheindahlen, Abitur (baccalaureate)