Practical experience leads to a new book on ISO 13485 quality management
The idea of writing a book based on practical experience from implementing the standard was born during the pandemic.
"The thought itself came about from collaboration with the Danish MedTech Bridge program, and I was lucky enough to find a great publisher from New York despite the lockdowns everywhere. So, maybe it’s fair to say that when the world feels like it’s getting small it’s also an excellent time to see how far you can then reach out.”, says Juuso.
The book is divided into 31 sections that correct easy misconceptions about implementing quality management and walk the reader further into the core of the standard section by section. The heart of the book is a section on the top 25 lessons to know before getting into quality management for medical devices. All the current topics of using the standard, from document control to post-market surveillance, are covered in the book. The transition to the new medical device regulation in the EU last year and the recent moves by the US FDA to adopt the standard in a big way both mean that the book is particularly topical right now.
Dr. Juuso has a doctorate in technology from the University of Oulu, Finland, and he acts as a committee member and a representative of Finland on several international standardization committees. He is also a Senior Advisor with the medical device quality consultancy Kasve Oy that specializes in business development, quality assurance and regulatory affairs, and software life cycle management.
The book, written in English, will be published globally on the 21st of March by Routledge. The book will be available as both a hardcover edition and a paperback edition through all major booksellers. You can find more information on the book and where to buy it at www.theqmsbook.com