Striving towards quality and compliance with all applicable regulations is the mission of every modern medical device company. ISO 13485 provides a framework for how to achieve this, and the first step in the implementation is to understand what the standard really requires. This whitepaper is designed to help top management and employees in organizations that have decided to establish and maintain an ISO 13485:2016-based Quality Management System by clearing up any misconceptions regarding the standard’s requirements.

In this document, you will find each clause of ISO 13485 explained in plain English in order to facilitate understanding of the standard, in the same order and number of the clauses of the standard. In addition, you’ll see links to additional learning materials.