Dr. Ilkka Juuso, DSc, has a doctorate in technology from the University of Oulu and 20+ years of experience working on R&D projects in both industry and academia. He is one of the founders of the medical device startup Cerenion, and its Chief Operations Officer and Quality Manager. Ilkka brings this experience to Kasve as a Senior Advisor influencing, for example, the development of the novel QAiRA-tool.
Ilkka’s main interests are international regulatory affairs (incl. EU MDD/MDR and US FDA), ISO 13485 quality management and medical-grade software development. Marketing and business strategy are also always close to his heart. At Cerenion Ilkka has led the development of an ISO 13485, ISO 14971 and IEC 62304 compliant Quality Management System (QMS) from the ground up, its subsequent day-to-day operation, and certification by a notified body.
He has also had a key role in the development and launch of a CE-marked Class IIb medical device under the Medical Device Directive (93/42/EEC) of the European Union. Ilkka has a deep involvement in quality and regulatory affairs, including participation in international standardization activities concerning e.g. quality management, healthcare software, artificial intelligence, and both lifecycle and agile methods in software development.
In his spare time Ilkka has reviewed some 3000+ films, developed a small technology company with his university colleagues, designed his family home and generally enjoyed family life.