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ISO-13485-2016

Understanding ISO 13485:2016 (E-Learning)

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E-Learning Content

This e-Learning course fully covers the ISO 13485:2016 requirements. ISO 13485 specifies requirements for quality management systems in order to achieve regulatory compliance in the medical device sector. Many medical device companies are utilizing ISO 13485 as a platform to build their business management systems because of its value or because third party certification is a specified requirement by customers and/or regulators.

This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.

Who Should Attend

This e-Learning course is designed for Quality Assurance Practitioners, Managers, ISO 13485:2016 Implementation Team Members and Management Representatives.

Recommended Training and/or Experience

A general understanding of quality management systems and a minimum of 3 months of relevant experience is recommended.

E-Learning Goals

  • Understand the application of Quality Management Principles in the context of ISO 13485:2016. Relate the quality management system to the organization’s medical devices, and provision of related services.

E-Learning Outline

  • Introduction and Welcome Chapter 1 – Introduction to ISO 13485
  • Chapter 2 – The ISO 13485 Standard Explained MD Written Exercise 1 (individual)
  • Chapter 3 – Overview of ISO 13485:2016 Requirements
  • MD Written Exercises 2a, 2b (Audit Scenarios)
  • Breakout Exercise 2c (Audit Scenarios)
  • MD Written Exercise 3 (individual)

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