ISO 13485: Medical Devices QMS - Requirements for Regulatory Purposes

About This eLearning

This two-hour course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard that serves as a basis for many medical device QMS regulations around the globe. This course covers the goals of the standard and detailed information on Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement.

Key Learning Objectives

By the end of this medical device ISO 13485 QMS course you will be able to:

  • Define the primary purpose of ISO 13485
  • Identify the general and documentation requirements of a QMS as outlined in Clause 4
  • Recognize the responsibilities of management in a QMS as outlined in Clause 5
  • Identify the resources needed to implement and maintain an effective QMS and to meet regulatory and customer requirements as outlined in Clause 6
  • Recognize the requirements for planning and developing the processes needed for product realization as outlined in Clause 7
  • Identify requirements for planning and implementing monitoring, measuring, analysis and improvement processes as outlined in Clause 8

Who Should Attend

This course is vital for any medical device quality professional including quality directors, manager, engineers and auditors responsible for implementing a quality management system in accordance with ISO 13485.


By completing/passing this course, you will attain the Medical Device Certificate.

Excellent course covering the medical device regulations and certification.