Medical devices training courses.

This course outlines the structure and scope of the IVDR, its rules, safety and performance requirements for CE marking and determining the conformity route.

This course introduces ISO 13485:2016 and gives delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS).

Learn about the MDR's structure & scope, classification & conformity routes, safety & performance requirements, and developing a post-market surveillance system.

Learn about the IVDR's structure & scope, classification & conformity routes, safety & performance requirements, and developing a post-market surveillance system.

This one-day course helps those who are responsible for managing the transition of their management system learn about the latest requirements of ISO 13485:2016.

This two day course enables medical device manufacturers to be audited only once for compliance with the standard and regulatory requirements of multiple authorities.

This IRCA registered four day course details the role & responsibilities of an Auditor/Lead Auditor, processes & planning, gathering evidence and evaluation of findings.

Learn how to design and implement an effective QMS based on ISO 13485:2016, prepare for certification or improve the effectiveness of your existing management system.

This two day course helps you improve your Quality Management System and understand best practice to conduct effective internal audits in accordance with ISO 13485:2016.

This course covers the changes introduced in ISO 13485:2016 and how it differs to ISO 13485:2003 so that you can adapt your Quality Management System.