In the first episode in our mini-series on AI Governance, Vik Khurana and Simon McDougall set out how organisations can kick off their programme, starting with the important work of identifying and assessing the use of AI, risk framework maturity, roles and responsibilities and high level risk and regulatory exposure. 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 h...
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In the first episode in our mini-series on AI Governance, Vik Khurana and Simon McDougall set out how organisations can kick off their programme, starting with the important work of identifying and assessing the use of AI, risk framework maturity, roles and responsibilities and high level risk and regulatory exposure. 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 h...
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 first episode in our mini-series on AI Governance, Vik Khurana and Simon McDougall set out how organisations can kick off their programme, starting with the important work of identifying and assessing the use of AI, risk framework maturity, roles and responsibilities and high level risk and regulatory exposure. 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 h...
