Use the code LOVE10 to redeem your savings when you enroll in a public training.

This offer ends February 29, 2024.

Enroll Today

Course Details

ISO 13485:2016 Transition

Course Area

Medical Devices

Course Duration

4 Hours

Continuing Education Units

0.4

Course Fee

No charge

There are no upcoming classes scheduled.

Request a quote for group training

Course Details

Are you already familiar with ISO 13485:2003/EN 13485:2012 and want to find out about ISO 13485:2016? This comprehensive course introduces you to the new requirements and explores the changes between ISO 13485:2003/EN 13485:2012 and the latest standard.

With greater attention on the organization's ability to meet applicable customer and regulatory requirements, ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management.

By attending, you'll be able to identify the gaps in your current QMS and start planning your transition and certification to comply with ISO 13485:2016.

How will I benefit?

This course will help you:

  • Recognize the key changes between ISO 13485:2003/EN 13485:2012
  • Understand how these changes may impact your current QMS
  • Explore the relationship between ISO 9001:2015 High level structure and ISO 13485:2016
  • Consider transition timelines and what resources may be required

What will I learn?

You will learn about:

  • Key changes between ISO 13485:2003/EN 13485:2012 and ISO 13485:2016
  • Revised terms and definitions
  • Relationship between ISO 9001:2015 HLS and ISO 13485:2016
  • Transition timelines and what resources may be required

Who should attend?

Anyone involved in planning, implementing, auditing or supervising an ISO 13485:2016 QMS transition.

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

Interested in a private or customized version of this course? Request a quote.

Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

Stay Connected