One of the founders of Cerenion, and the person responsible for the development of its quality management system, Dr. Ilkka Juuso, has written a book on quality management for medical devices. The book is based on seven years of hands-on experience and extensive networking in the field, the results of which are presented as lessons and advice through the 352 pages of the book.
‘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 a 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 Ilkka 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.
COO, Quality Manager & Co-Founder of Cerenion