ISO 13485 Training Courses

Designed to increase your knowledge on the requirements of ISO 13485:2016 Quality Management System Standard, key principles and interaction with ISO 9001:2015.

This two-day course has been designed to provide an in depth understanding of ISO 13485:2016.

Increase your understanding of ISO 13485 scope, structure and requirements and identify the systems needed to implement an effective QMS in your organization.

This two-day course has been designed to increase your knowledge on how to effectively implement a Quality Management System according to ISO 13485:2016 requirements. The course introduces key concepts to understand, develop and implement an effective QMS.

This intensive two-day course is intended for medical device quality professionals aiming to increase their knowledge on ISO 13485:2016 to increase effectiveness of their organization QMS for internal auditing purposes. Learn best practices to improve your QMS audit process compliance to ISO 13485:2016 and ISO 19011:2018.

The course focuses on key principles and practices for effective Quality Management System audits according to ISO 13485:2016 and ISO 19011:2018. Experienced instructors will guide you throughout the audit process, from its management to results reporting. Increase your knowledge and develop additional skills to plan, conduct, report and follow-up a compliant QMS audit.