ISO 13485:2016 is the international standard for medical device quality management systems, providing organisations with a structured approach to ensure product safety, regulatory compliance, and consistent quality. This course introduces learners to the principles, framework, and practical applications of the standard, highlighting its relevance across the medical device lifecycle.

This course opens with an exploration of the origins and evolution of ISO 13485:2016, highlighting its relationship with ISO 9001 and the global regulatory factors that shaped its development. You’ll gain insight into key terminology and quality management principles, building a strong foundation for applying the standard across diverse organisational settings.

Moving forward, the course delves into the practical operation of a Quality Management System (QMS) — from documentation structures and record control to leadership, resource allocation, and product realisation. Through real-world examples, you’ll learn effective strategies for integrating ISO 13485:2016 requirements into every stage of medical device design, development, procurement, production, and service delivery.

This course content was created in partnership with Dr. Anadu Austin, a Medical expert and Consultant. For more information on our subject matter expert, visit https://www.linkedin.com/in/austin-anadu-9a8346244/

The authors generated this text in part with GPT-4o, OpenAI’s large-scale language-generation model. Upon generating draft language, the authors and subject matter experts reviewed, edited, and revised the text to ensure it reflected accurate expertise and met high pedagogical standards.

Enrol now to develop essential skills, confidently apply ISO 13485:2016 standards, and advance your expertise in medical device quality management.