ISO 13485:2016 Overview

Provided by: MEP Courses

This workshop will provide you with a concise but detailed review of the new ISO 13485 Medical Devices Quality Management System standard. We will compare the 2016 version to the 2003 version, and explain the new requirements of the 2016 standard. We will also talk about transitioning from to the 2016 standard, including timing requirements. Activities include developing a ├ČList of Interested Parties├« for your QMS. There will also be time for questions and answers.

Course Objectives:

  • Describe the history and purpose of ISO 13485

Recommended Background

  • Management representatives, quality professionals, personnel functioning as internal auditors

Course ID



Company Choice


Purdue University MEP


Communication, Critical Thinking, Personal Effectiveness, Functional Auditing

Method of Delivery

Face to Face

Estimated Effort

4 hours