Medical device manufacturers and sponsors need to understand and comply with the current Quality Management System (QMS) standard ISO 13485:2016. 

This 2-day training course will provide you with the knowledge, skills and tools to implement a QMS in compliance with the ISO 13485:2016 standard. 

Ultrasound medical device

At the end of this course you will be able to:

  • Know your legal obligations as a sponsor or manufacturer
  • Understand the success factors for an effective QMS and the benefits it delivers
  • Develop risk management strategies for products and processes
  • Determine if your organisation is ISO 13485 audit-ready
  • Develop plans to streamline your QMS and maintain practical compliance


The course will provide a short introduction to the regulatory landscape of Quality for medical device companies followed by practical advice to help you implement a QMS across the four (4) key areas of ISO 13485.  It will cover:

  1. The Regulatory Environment
  2. The ISO model for an effective process-based QMS
  3. The application and integration of a Quality Risk Management (QRM) framework
  4. Key areas of ISO 13485 (including changes in the 2016 standard)
    • Management responsibility
    • Resource management
    • Product realisation
    • Measurement, analysis and improvement


This course will assist organisations preparing for ISO 13485 certification (or re-certification to the 2016 standard). It will also be of interest to businesses that supply to ISO 13485 regulated companies.  Business types that have benefited from ISO 13485 training include:

  • Medical device design and manufacturing groups
  • Medical device sponsors whose products are manufactured in other regions and then distributed in Australia and Europe
  • Pathology companies
  • Suppliers to medical device companies looking to gain a competitive edge

Format and Course Length: 

The 2-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.

Contact us and register your interest in a public session or having this course delivered on-site.

Refer to the Terms and Conditions