This EASY to understand book is ideal for all (Employees & Employers) and other people who are new to MDSAP, ISO 13485, (International Standard) who want to get more out of an established Quality Management System (QMS). Particularly for employees who just need a basic understanding of what MDSAP is and how it applies to them. This Book was written so that anyone at any level of the organization can get to the heart of the standard's requirements and how they apply to the organization quickly and simply.