What is required to demonstrate compliance to the IVDR regarding Risk Management? How do I perform risk analysis, and estimate probability and severity? How to deal with legacy devices? 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 Risk Management and provide you with tools whether you need update your existing Risk Management Files or build it “from scratch”.
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 update Risk Management File and corresponding parts of the Technical Documentation, to demonstrate compliance to IVDR and ISO14971:2019.
The course is suitable for persons involved in Risk Management, or Design & Development of In-Vitro Diagnostic devices, such as: Design engineers, Quality specialists/Engineers, but also QA/RA Managers.
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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