ISO 13485:2016 Foundations Training

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