Ilkka Juuso and Ilpo Pöyhönen's book Medical-Grade Software Development is now available for pre-order.
Ilkka Juuso, who has also authored a book on ISO 13485 quality management (Routledge 2022), and Ilpo Pöyhönen from SGS Finland, who has over 30 years of experience in evaluating the safety of medical devices, joined forces to delve deep into the development of medical software. Their collaboration resulted in a book that brings together the requirements of ISO 13485 quality management and IEC 62304 software development.
"Both quality management and software lifecycle model requirements apply to software-based medical devices, but constructing a comprehensive view of their combination has been challenging. This book is the first practical presentation of a comprehensive solution," says Ilkka.
The 360-page book, now available for pre-order from the American-English publisher Routledge, is structured into practical sections, each delving into a required work phase or aspect of medical software development. The book also discusses the future outlook of key ISO 13485 and IEC 62304 standards and other relevant current standards (such as IEC 82304-1 and IEC 81001-5-1).
"This project has been a remarkably interesting dive into the requirements of software development. The project, which lasted for over 18 months, has allowed us to collaborate and develop practical answers to many questions that have emerged in past years," says Ilkka.
"It has also been pleasing to see that there is a clear demand for this book as I've travelled around the world."
The book can be pre-ordered through all major bookstores starting October 23, and deliveries will begin November 13.
Ilkka has served as a committee member and Finland's representative in the international standardization of medical devices within ISO for several years. Since January 2023, he has also been a part of the leadership team of the Central Health Informatics Committee in Europe on behalf of CEN.