Webinar
Medical Devices

Pathways to IVDR compliance

This webinar presents an overview of the key aspects of IVDR compliance, focusing on technical documentation and Performance Evaluation.

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This Webinar:

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.

Contributors

Pathways to IVDR compliance

Overview of IVDR compliance, focusing on pitfalls related to technical documentation and Performance Evaluation requirements under IVDR Regulation.

Contributor
Elizabeth Harrison

Global Head - IVD, BSI.
Contributor
Alex Laan

Head of IVD Notified Body, BSI.
Contributor
Todd Moorman VP

IVD Sales Solution, Americas, BSI.

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