Which elements need to be covered by your Quality Management System, to achieve CE-certification for in-vitro diagnostic devices? What is the responsibility of the PRRC, in relation to the QMS? What will the NB need look for when auditing our Quality Management System?
This training will give you the answers!
After this half day training you will be better equipped to tackle the questions above.
We’ll walk you through the key IVDR requirements on your Quality Management System and provide you with tools to perform a gap analysis and perform an update of your quality management system, to ensure compliance with the IVDR. The relationship between ISO13485:2016 and IVDR, and the role & responsibilities of the PRRC will be clarified.
To get the full understanding of IVDR requirements on Quality Management System, Risk Management and the Technical File – combine this course with:
Completion of this course will give you the knowledge needed to assess and update your current quality management system for IVDR compliance, make use of ISO13485:2016 to manage key regulatory requirements and apply a risk-based approach.
Quality Managers, Quality Specialists/ Engineers, RA Managers/Specialists, Management team members, the PRRC (Person Responsible for Regulatory Compliance), the Management Representative, of an IVD Manufacturer.
Note. To register for a public course/event – Use the button “ADD TO CART” above.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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