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This webinar presents an overview of the key aspects of IVDR compliance, focusing on technical documentation and Performance Evaluation.
History Lesson: Key IVDR changes… why and when?
Telling a Story: Creating effective technical documentation.
Clinical Evidence: Understanding the requirements.
High Risk update: Current status of CDx & Class D devices.
Overview of IVDR compliance, focusing on pitfalls related to technical documentation and Performance Evaluation requirements under IVDR Regulation.
Global Head - IVD, BSI.
Head of IVD Notified Body, BSI.
IVD Sales Solution, Americas, BSI.
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