ISO 13485 is the standard when it comes to quality management in the context of medical devices. It is the present day in Europe and Canada, the next state-of-the-art in the United States, and the tomorrow in the rest of the global market. Through the Medical Device Single Audit Program (MDSAP), too, it applies from Brazil to Australia and Japan to the US. Knowing about the standard is required. Learning how to turn it into a business advantage is a must.
Getting to grips with the standard may seem daunting, we know. Don't worry. The standard makes a lot of sense if you learn it right. The book "Developing an ISO 13485-Certified Quality Management System - An Implementation Guide for the Medical-Device Industry" (Routledge 2022) by Dr. Ilkka Juuso is written to ease you into using the standard, and help you make the most of it.
The 350-page book is broken down into lessons you should know when diving into quality management, and the essentials of what goes into the Quality Manual and the Standard Operating Procedures you'll need to obtain compliance with the standard. The book is based on real-world examples and experience you can benefit from, right from the start or when you keep improving your QMS.
Over time we hope to build on this site so that you can read more about the book, access additional materials, reach out to us, and a lot more here. The book itself is widely available, both as a PAPERBACK and a HARDBACK version, from all major booksellers around the world, and on this site we provide a few of those links.