Will Notified Bodies accept the use of AI by medical device manufacturers?

And perhaps more importantly, what does responsible AI use in Regulatory Affairs actually look like?

In this episode, Steven Byrne from Scarlet joins us to explore some of the questions manufacturers and Notified Bodies increasingly need to address.

Can manufacturers use AI to prepare technical documentation, review clinical evidence, identify inconsistencies, or support regulatory decision-making?

How do we validate AI tools when their outputs are not always deterministic? What level of human oversight is necessary? And how do we demonstrate that AI genuinely adds value rather than simply generating more documentation to review?

These are no longer theoretical questions. Manufacturers are already using AI, and Notified Bodies will increasingly encounter AI-assisted documentation and assessments.

What I particularly admire about Scarlet is their willingness to engage openly with these questions and challenge conventional approaches to conformity assessment. Rather than treating AI simply as a risk, they are contributing to a much-needed conversation about how technology, expert judgment, and trust can work together.