ISO 13485:2016 Foundations

  • Delivery Option: Public & On-Site
  • Subject Category: Auditing
  • Cost: $1095
  • Number of Days: 2 days

Course Summary

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

  • 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

Target Audience

Those who want to understand the requirements of ISO 13485:2016, those responsible for planning and scheduling an internal audit program for ISO 13485:2016, and those who must perform audits to ISO 13485:2016 – manufacturing, suppliers, managers, or anyone interested in conducting first-party, second- party, or third-party audits.

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