Compliance Training Medical Device Training Details
$549 USD

Implementing ISO 13485

This course will introduce the requirements of ISO 13485 and outline the steps for building an ISO 13485 compliant quality management system.

 

  • English
  • Certificate of completion
  • 3 hours
  • Regulatory / Quality Assurance
  • 1 year

Overview

This course is for managers and professionals in the medical device industry implementing ISO 13485.

There are no prerequisites.

There are three sections. Each section includes a video, followed by interactive exercises that allow you to work with the information, and practice using it using real-world scenarios.

Gain experience and a deeper understanding of ISO 13485:2016 requirements and how to build a quality management system to meet those requirements.

There are interactive exercises within the training which you must pass, with a score of 80%, in order to move on to the next. If you do not pass, you may try again.

There is a final quiz which you also must pass with 80%. It is not timed and if you do not pass, you may try again. You are able to go back and review chapters that you have already completed.

Read full overview

Agenda

  1. Quality Management Systems
  2. Requirements of ISO 13485:2016
  3. Steps for implementing an ISO 13485:2016 compliant quality management system
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