What is required from your technical documentation to achieve CE-certificate for your in-vitro diagnostic devices? How do I manage the coordination between GSPR, Performance Evaluation and Risk Management? When do I need to perform a Biological Evaluation? What does the Notified Body expect from us? How to deal with Class A 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 your Technical Documentation and provide you with tools whether you need to perform a gap analysis of an existing Technical File, or start 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 assess and update your current technical documentation for IVDR compliance.
You will learn how to:
The course is suitable for persons involved in Design & Development of In-Vitro Diagnostic devices, or writing or maintaing Technical Documenation, such as: Design engineers, Head of R&D, Regulatory Affairs Managers or Specialists, or Quality specialists/Engineers.
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