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