Understanding and Implementing ISO 13485:2016

To implement an ISO 13485:2016 Medical Devices Management System, you need an understanding of how to interpret and apply the requirements for your organization. This course provides a general understanding of the standard and how the requirements impact the daily operations of medical device organizations. ISO 13485:2016 requirements are reviewed and interpretations shared with the class, including “why do this” and what it takes to implement conforming practices. The course explains how to prepare for certification body audits and what happens in the registration process. Students receive a comprehensive course manual.

 1/28, 2/18, 3/10
Phoenix, AZ
Tucson, AZ
  • Understand Management System Purpose, Concepts and Guidelines
  • Understand the Structure of ISO 13485:2016
  • Understand the Requirements of the ISO 13485:2016 Standard
  • Understand the Eight Quality Management Principles
  • Understand the Process Approach
  • Recognize the Role and Responsibility of Management
  • Recognize the Benefits of a Medical Device Management System
  • Gain an Introduction to an Implementation Roadmap and the Process for Registration


This course is delivered as a one-day class from 8:00 a.m. to 5:00 p.m.


This course is intended for anyone requiring an understanding and working knowledge of the standard. More specifically, business owners, senior managers, project managers, supervisors, quality managers, management representatives, or anyone interested in the application and benefits.


This is an introductory course and no previous knowledge is required.


The course is $370.00 per student (reduced pricing available based on the number of students). To confirm your enrollment, pre-payment through PAYPAL or company confirmation is required.


If you have any questions about this course, please call us toll free at 888-572-9642. You can also e-mail us at admin@sustainingedge.com