ISO 13485:2016 Foundations Training

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

Description

This is a two-day, instructor-led classroom course. There is a written exam at the end of day 2.

Course Objectives

  • 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

Have questions? Contact us

DEKRA Training

8990 Springbrook Dr. NW

Suite 210

Minneapolis , MN 55443

+1 800.633.2588
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