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

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 largest Medical Device Regulation-designated notified bodies told