What is the current thinking from regulators/NB’s on Raiana and similar applications ?

Our discussions with regulators and NBs so far really show two views on Raiana and other AI tools.

The first perspective, what you’re probably referring to, is what they expect a manufacturer to do when they introduce Raiana in their workflow. The answer there is: no different than any other tool. If AI were to drive decisions by itself, it would of course require very thorough validation. But because it is about regulatory augmented intelligence, it is more a case of integrating human review of AI outputs into standard operating procedures. Just like you have human review of human outputs as well.

Episode 1 of the Augmented Professional webinar was dedicated to introducing regulatory AI tools in your QMS and validating the tools. You can watch the video here:

The other perspective is use of AI by the notified bodies and regulators themselves. Just like the FDA has introduced Elsa and will probably not be buying Raiana (if we’re wrong, FDA, you have our number!), probably almost all notified bodies are also looking at tooling to help them do their work better and faster. As manufacturers adopt AI to be able to respond faster and more thorough, the notified bodies will want to keep up. Both sides are interested in AI and at Raiana, we want to serve both as well.