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.

Speakers

Hear from the experts in this webinar

Speaker

Elizabeth Harrison

Global Head - IVD, BSI

Speaker

Alex Laan

Head of IVD Notified Body, BSI

Speaker

Todd Moorman VP

IVD Sales Solution, Americas, BSI

Insights & Media

Find out more from global experts in healthcare standards

Informatie en media

EU MDR – Post Market Clinical Follow-Up

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Annex XVI - Devices Without an Intended Medical Purpose

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Using Standards to Demonstrate Conformity

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Unlocking the Potential of Consumer Wearables in Healthcare

Lees het whitepaper

Medical Device Lifetime - Assisting manufacturers

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Symbols & Details Required for Medical Devices & IVDs

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