In the second episode of our series on AI Governance, Vik Khurana and Simon McDougall set out how organisations can design and implement AI governance into their organisations, covering the gap analysis required, risk classification tools, regulatory mapping and requirements inventory. Send us a text Thanks for listening! If you have any feedback, questions or comments, please email us at theroadmap@bristows.com Find all the episodes as we release them here, and don’t forget to sub...
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In the second episode of our series on AI Governance, Vik Khurana and Simon McDougall set out how organisations can design and implement AI governance into their organisations, covering the gap analysis required, risk classification tools, regulatory mapping and requirements inventory. Send us a text Thanks for listening! If you have any feedback, questions or comments, please email us at theroadmap@bristows.com Find all the episodes as we release them here, and don’t forget to sub...
Medical device software market on the brink? The AI Act alarm bells are ringing - Part 3
The Roadmap
7 minutes
5 months ago
Medical device software market on the brink? The AI Act alarm bells are ringing - Part 3
In this final episode of our three-part mini series on the EU AI Act and its implications for manufacturers of medical devices, Marc Dautlich and Alex Denoon look in detail at Annex V of the Act. Annex V of the EU AI Act requires, amongst other things, that a manufacturer provide the Notified Body making a conformity assessment with a statement that the high risk AI system that is being assessed and which forms part of the medical device, and which involves the processing of personal da...
The Roadmap
In the second episode of our series on AI Governance, Vik Khurana and Simon McDougall set out how organisations can design and implement AI governance into their organisations, covering the gap analysis required, risk classification tools, regulatory mapping and requirements inventory. Send us a text Thanks for listening! If you have any feedback, questions or comments, please email us at theroadmap@bristows.com Find all the episodes as we release them here, and don’t forget to sub...
