MDR Audit Readiness – how to determine if your Quality Management System is MDR compliant
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This online-course provides you with a full understanding of MDR specific requirements on your Quality Management System, including an exhaustive review of the differences and similarities between ISO13485:2016 and the MDR QMS requirements.
Course description
- Which parts of my 13485 certified-quality system need to be updated and how?
- How do I establish an efficient feedback loop between Risk management, Clinical evaluation and Post-Market Surveillance without creating “document overload”?
- As legal manufacturer, am I responsible to inform distributors about their new responsibilities?
- What is my responsibility as subcontractor/contract manufacturer towards a legal manufacturer?
- As there is currently no MDR-harmonized standards, how do we proceed in the meantime?
After this one day course you will be better equipped to tackle the questions above. We’ll walk you through the key MDR requirements on the Medical Device quality management systems and provide you with tools to perform an efficient MDR gap analysis of your quality system. The relationship between ISO13485:2016 and MDR will be discussed and the MDR requirements that are not covered by the standard pointed out.