MMD-101    Understanding the Requirements of ISO 13485:2016 Quality Management System for
                      Medical Devices

  • Overview
  • Course Objectives
  • Course Content
  • For Whom
  • Schedule and Hours
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ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS.
  • Understanding of ISO 13485: 2016 requirements
  • Review of the requirement for changes
  • Understanding the product safety and regulatory requirements
  • Extend of the changes and its implications.
  • Overview of the purpose and requirements of a risk management system (RMS) based on the principles of ISO 14971.
  • Introduction to ISO 13485
  • Understanding of Standards
  • Risk Management
  • Medical Devices
This course is designed for individuals in the medical device industry who are involved in the development of a quality management system.
This is 1-day programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

​Public Training Schedule:
N/A