Module 12 Presentations

07/02/2024

AI / Cyber Real World Examples

• Presenter: Paul Fletcher-Dyer

Global AI Compliance Director and cDPO

www.linkedin.com/in/paul-fletcher-dyer-37baa123

02 nd February 2024

The Organisation for Professionals in Regulatory Affairs

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UK Medical Devices Regulation Label

• An example of a label for software • Hyperlinks to IFU’s, contraindications etc are acceptable • The UKRP is a new requirement • The Version number is for the app – but what if the MD algorithm has it’s own version number? Should that be on the label too?

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