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  • Webinar
    Medical Devices

Shaping Trust in AI - Ensuring Conformity of AI enabled Medical Devices

Understanding the challenges to AI-enabled Medical Device conformity assessments.

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Ensuring Conformity of AI – enabled Medical Devices amid Regulatory Changes

This webinar will identify gaps regarding specific requirements of AI conformity assessment and discuss the impact on the medical devices industry.

  • Identify gaps regarding specific requirements of AI conformity assessment.

  • Significant impact on the medical devices industry as well as ongoing debates.

  • AI-enabled medical devices’ model changes.

  • Substantive modification and triggering a new conformity assessment.

Shaping Trust in AI - Ensuring Conformity of AI enabled Medical Devices

As the AIA is expected to enter into force in 2024 and be applicable in 2026, planning for its implementation should start now.

Aris Tzavaras, Head of AI Notified Body, BSI

Inma Perez Ruiz, Regulatory Lead, AI Notified Body, BSI

Alex Laan, Head of IVD Notified Body, BSI
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