Medical-Grade Software Development: How to Build Medical-Device Products That Meet the Requirements of Iec 62304 and ISO 13485

This book is a practical guide to meeting IEC 62304 software development requirements within the context of an ISO 13485 quality management system (QMS). It proves it can be done with a minimum amount of friction, overlap, and back-and-forth between development stages.

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 Senior Advisor with the medical device quality consultancy Kasve, and a post-doctoral researcher with the University of Oulu.

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 CEmarked Class IIb medical device based on artificial intelligence.

He has 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).

Ilpo Pöyhönen has 30-plus years of experience working on medical device research, development, testing, and safety &
performance evaluation including in the context of an accredited certification body. During that time, he has performed approximately 200 software evaluations according to IEC 60601-1-4, IEC 60601-1 cl.14, IEC 62304, and IEC 82304. Particular areas of interest in this work have been the role of programmable database systems and the development of test equipment for diverse needs. The work has taken him across the globe and even to the edge of space.

Today his main interests are international regulatory affairs, standardization, and the intelligent control of medical device design processes to continuously meet the requirements imposed by, for example, cyber security, usability engineering, risk management, and agile development models. The use of emerging technologies, such as artificial intelligence, also holds special interest to him.

He has been active in research initiatives that have, for example, examined the software development documentation required in a regulated environment, the impact of risk management, the performance of risk analysis itself as part of the software development life cycle, and the reliability factors involved in the supply of complex software systems.

He is a long-time committee member of SFS/SR301 on healthcare IT and a sought-after lecturer on topics such as medical device software, risk management, usability, mHealth APS, and cloud services in the context of medical devices.