Compliance with the EU’s AI Act for Class IIa or above AI-related medical devices is not a cause for panic, according to Stephen Gilbert, a professor of medical device regulatory science. He suggests that those already preparing for compliance with the EU Medical Device Regulation (MDR) can expect a similar process for the AI Act.
The European AI Act is a regulatory framework proposed by the European Commission to ensure that AI is developed and used ethically, transparently, and accountably. It categorizes AI applications based on their risk levels, from minimal to high, and mandates different levels of scrutiny and oversight accordingly.
The EU AI Act presents both challenges and opportunities for organizations, emphasizing the importance of robust data governance to ensure responsible AI development. By aligning data practices with the Act’s requirements, companies can enhance operational efficiency, build trust, and gain a competitive advantage in the market.
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