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ISO 13485:2016 Foundations Training

17. to 18. Jan 2022

New Orleans, LA

2 Days - 1.6 CTUs - $1095 - Competency Unit MD

Understand the requirements of the ISO 13485:2016 Quality Management System standard


This is a two-day, instructor-led classroom course. There is a written test at the end of the second day.

Course Objectives

After this course, you will be able to:

  • Describe the ISO 13485 Medical Device Quality Management System (QMS) Requirements for Regulatory Purposes standard and development process
  • Identify medical device QMS terms
  • Describe the intent and requirements of ISO 13485:2016
  • Determine the evidence needed to demonstrate conformity to ISO 13485:2016
  • Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
  • Describe the relationship between ISO 13485:2016 and applicable regulatory requirements

Certified by Exemplar Global

Contact Us

DEKRA Training

8990 Springbrook Dr. NW

Suite 210

Minneapolis , MN 55443

+1 800-633-2588