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In-Person Training consists of public classes conducted by one of our subject matter experts at one of our designated locations in one or more consecutive days.
- Fully understand and successfully interpret the ISO 13485 requirements
- Identify medical device QMS terms
- Understand how to audit using the process approach
- Ask audit questions that get results
- Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
Learn to plan and schedule an internal audit program for medical device quality management systems. Develop the skills you need to conduct a successful audit in this course devoted to the ISO 13485:2016 Medical Device Quality Management System standard. This three-day class begins with foundational knowledge of the ISO 13485 standard and builds upon it to prepare you for real-life auditing situations—including managing the audit process and completing reporting—via hands-on workshops and two competency exams (MD & AU).
All attendees are required to bring their own copy of the standard ISO 13485:2016 Quality Management System – Requirements For Regulatory Purposes. Copies will not be provided for you.
Training Time: 24 hours
Continuing Education Credits (CEUs): 2.4
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