Are Notified Bodies AI-Ready? BSI Teams Up With Expert Firm On Conformity Assessments

BSI Group has partnered with Japan’s Citadel AI to ensure that where necessary, medical devices based on artificial intelligence (AI) are assessed rigorously for regulatory compliance. The notified body explains why this partnership is necessary for complex AI products.

AI Handshake
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With the EU AI Act set to enter into force within the next few years, medtech companies should be making provisions to ensure their products are compliant with new requirements. It is not just manufacturers, though, who must prepare for rigorous conformity assessments - notified bodies alike will need to ensure they have the tools in place to ensure AI-based medtech products are safe, trustworthy and effective.

“There is increasing scrutiny around high-risk AI systems, and this is a fast-developing and highly complex field,” Mark Thirlwell, managing director for AI at BSI Group, one of the EU’s...

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