ISO 13485:2016 Foundations Training
2 Days - 1.6 CTUs - $1195 - Competency Unit MD
Understand the requirements of the ISO 13485:2016 Quality Management System standard
Format
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
DEKRA Training
8990 Springbrook Dr. NW
Suite 210
Minneapolis MN 55443