ISO 13485:2016 – Awareness Training (Online)

This online introduction course provides you with a fundamental understanding of ISO 13485:2016 and the key requirements for quality management systems related to medical devices.

The course is designed for you who work with or influence the company’s quality system, processes, documentation, or regulatory activities. Participants will be introduced to the structure of the standard and its main requirement areas, including documentation, management responsibility, risk-based thinking, competencies, process control, nonconformities, CAPA, and continual improvement.

The course also focuses on how the requirements of ISO 13485:2016 can be applied in daily operations and how the standard supports quality, compliance, and patient safety.

The training is conducted online and combines presentations, practical examples, and interactive discussions.

Learning Objectives

After completing the course, you will have:

• A basic understanding of ISO 13485:2016
• Insight into the structure and key requirements of the standard
• An understanding of quality management principles for medical devices
• Awareness of the relationship between compliance, quality, and patient safety

The course also supports documented training and competency requirements related to relevant clauses of ISO 13485:2016.

Target Audience