Course Curriculum

    1. How to use this course

    1. ISO 13485:2016 Quick Reference Guide

    1. ISO 13485-Lesson-02

    2. ISO 13485-Lesson-01 and 02-QUIZ

    1. ISO 13485-Lesson-03

    2. ISO 13485-Lesson-03-QUIZ

    1. ISO 13485-Lesson-04a

    2. ISO 13485-Lesson-04b

    3. ISO 13485-Lesson-04-QUIZ

    1. Video-Summary-Leadership requirements

    2. ISO 13485-Lesson-05

    3. ISO 13485-Lesson-05-QUIZ

ISO 13485:2016 Requirements

  • $695.00
  • On Demand / Student-Paced
  • 16 hours / 1.6 CEUs
  • English
  • Exemplar Global Certified

Learning Objectives

  • Understand quality management definitions, concepts, and guidelines for ISO 13485:2016

  • Know the requirements of the ISO 13485:2016 standard

  • Understand the process approach

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