Understanding ISO 13485 Requirements: Management Systems for Medical Devices

Course Description

What exactly does ISO 13485 require?  How should I implement it in my manufacturing plant?  This course will answer these questions in detail using an entire Resources Section devoted to sample documents you can customize to your plant. In addition, the course provides guidance on the ISO 13485 relationship with FDA regulations and similar requirements in Canada, Europe and South America.  If you are looking to expand your market overseas, this course will show you what doors are open to you.

Download the course brochure here.

Course ID: QUAL 1117P
Course Format: Classroom

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View previous sections
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CRN Start date End date Format Location Cost
14489 Oct 28, 2014 Oct 29, 2014 Classroom Atlanta, GA $895
15508 Apr 28, 2015 Apr 29, 2015 Classroom Atlanta, GA $895
15544 Oct 27, 2015 Oct 28, 2015 Classroom Atlanta, GA $895
16358 Apr 26, 2016 Apr 27, 2016 Classroom Atlanta, GA $895
16377 Oct 24, 2016 Oct 25, 2016 Classroom Atlanta, GA $895
17404 Mar 28, 2017 Mar 29, 2017 Classroom Atlanta, GA $895
17405 Oct 24, 2017 Oct 25, 2017 Classroom Atlanta, GA $895

Special Discounts

There are discounts available for this course. Please use one of the coupon codes below at checkout. Note: Only one coupon code can be used per shopping cart.

Groups: If 2 or more people from your organization are registering for this course, you can recieve 10% off.  Use coupon code MULTI.

Who Should Attend

Those responsible for quality and risk management in the medical devices field

How You Will Benefit

  • Champion ISO 13485 plant benefits.

  • Describe ISO 13485 standard requirements.

  • List the steps to implement ISO 13485.

  • Prepare an action plan to get started.


  • Benefits of ISO 13845

  • Document overview

  • Requirements for clauses 4-8

  • International relationships

  • ISO 13845 implementation action plan



  • Attendees must purchase a copy of the standard ISO 13485:2016 Medical Devices – Quality management systems – Requirements for regulatory purposes and bring it to class.
    The standard may be purchased through the American National Standards Inst. (ANSI) and/or American Society for Quality (ASQ).


  • Notebook with Resources Section of sample documents

For Course-Related Questions

Please contact the course administrator: Carol Aton