Software- and cybersecurity-specific IVDR requirements: Challenges for regulatory compliance and testing approaches

In contrast to the IVDD, the IVDR’s conformity assessment of programmable electronic systems (devices that incorporate software systems or software that is a device in itself) is disproportionally more demanding. Based on the IVDR requirements, our expert Dr Alexander Stock will explain why cybersecurity is critical when designing, developing, and upgrading IVD medical devices during their life cycle. You will also learn why high-quality test evidence is essential to a successful Notified Body conformity assessment.

Date and time: Thursday, 27 October 2022, 11.00 am (CEST) / 5.00 am (EDT)

Your speakers: Dr Alexander Stock, Project Manager In Vitro Diagnostic Medical Device Testing

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