ISO 13485 Foundation Course Overview

The ISO 13485 Foundation course is designed to introduce learners to the key concepts and requirements of the ISO 13485:2016 standard, which pertains to the Quality Management Systems (QMS) for medical devices. This course equips participants with the baseline knowledge necessary to understand and implement the standards within an organization, ensuring that medical devices meet both customer and regulatory demands.

Module 1 provides an overview of the ISO 13485:2016 standard and underscores its significance for organizations in the medical device industry, while Module 2 delves into the specific QMS requirements, including general and documentation needs, Management responsibility, Allocation of resources, Product realization, Infrastructure, and risk management.

By the end of the course, those who complete the ISO 13485 training will be well-prepared to contribute to their organization's objectives and may have the opportunity to take a certification exam to earn their ISO 13485 certification. This foundation is crucial for professionals aiming to ensure quality and compliance in the highly regulated medical device sector.