Course Description

ISO 13485: Foundation and Basic Principles

Course Description:

This course introduces participants to the international standard “ISO 13485 - Medical devices - Quality management systems -Requirements for regulatory purposes” and will take you step by step through the requirements of the standard while providing the necessary explanations to ensure that the requirements and logical quality system links are understood.


ISO 13485 is the reference standard for quality systems for medical device manufacturers in many regulatory systems across the globe and this introductory course will assist participants in acquiring the foundation and basic principles involved to overcome any reserves before moving on to studying the applicable guidance documents of the ISO / TR 14969 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003.

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Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • Comprehend and define the basic principles of ISO 13485
  • Participate in the process of implementation of a quality system

Who Should Enroll:

Quality Management staff new to medical devices, Regulatory staff seeking for a “refresher” in quality system requirements, Management staff not directly in charge of compliance issues wanting to get an overview.

Prerequisite Knowledge/Requirements:

Being familiar with other quality system standards or regulations as for example ISO 9001. Having available the ISO / TR 14969 guidance.

Subject Matter Expert:
Maria Cianciotto

152 min

Release date:

Related resources:

Case studies:

Basic Account: € 304.00
Premium Account: € 228.00

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