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