Course Description

ISO 13485:2016 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes

Course Description:

This course introduces the updated 2016 version of the 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 13485:2016
  • A step-by-step guide of ISO 13485:2016 requirements
  • Detailed explanations of each requirement and quality system links between the requirements

Learning Objectives:

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

  • Build a strong foundation of the basic principles of ISO 13485:2016
  • 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.  In addition, any staff member who has taken the ISO 13485:2003 course should take this updated version with all the new requirements that were included in the ISO 13485:2016 standard published March 1, 2016.

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 13485:2016 standard

Subject Matter Expert:
Carole Stamp

183 min

Related resources:

Case studies:

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