Course Description

ISO 13485: Foundation and Basic Principles

Course Description:

This course introduces ISO 13485: “Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes,” the international reference standard for quality systems for medical device manufacturers in regulatory systems across the globe. 

This course covers the following topics:

  • Basic principles of ISO 13485
  • A step-by-step guide of ISO 13485 requirements
  • Detailed explanations of each requirement and quality system link

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Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Build a strong foundation of the basic principles of ISO 13485 before moving on to the applicable guidance document ISO/TR 14969: “Medical Devices - Quality Management Systems - Guidance on the Application of ISO 13485: 2003”
  • Participate in the process of implementing a quality system

Who Should Enroll:

Quality management staff who are new to medical devices, regulatory staff seeking a refresher in quality system requirements, and management staff not directly in charge of compliance issues but wanting an overview are all encouraged to take this course.

Prerequisite Knowledge/Requirements:

The following material is required:

  • Familiarity with other quality system standards or regulations, such as ISO 9001
  • A copy of the ISO/TR 14969 guidance

Subject Matter Expert:
Maria Cianciotto

152 min

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Basic Account: € 304.00
Premium Account: € 228.00

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