Ilkka Juuso

Dr. Ilkka Juuso, DSc, has 20-plus years of experience working on multidisciplinary R&D projects in both industry and academia. He is one of the founders of the medical device startup Cerenion, a Principal Regulatory Engineer with the medical device quality consultancy Kasve, and a post-doctoral researcher with the University of Oulu in Finland.

His main interests are international regulatory affairs, standardization, and healthcare business development. He has successfully 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 had a key role in the launch of a CE-marked Class IIb medical device based on artificial intelligence.

Ilkka’s areas of expertise include:

• ISO 13485 quality management
• Development of medical devices and software
• The role of standards in response to legislative requirements
• International standardization work

He has also repeatedly served as a committee member and the head of the Finnish national delegation in key committees of the International Organization for Standardization (ISO). He is also the author of the book “Developing an ISO 13485-Certified Quality Management System” (Routledge 2022).