At the 10x MedDev Conference in London, I spoke in detail about the regulatory definition of state of the art, comparing how MDR, ISO 14971 and MedDev 2.7 define state of the art (or not).
This continues to be one of the topics that generates the most comments whenever I post about it on LinkedIn.
Did you know that SOTA actually has a lifecycle? Are you clear on how SOTA and standard of care intersect? Listen in on the presentation, and all will be revealed.
Still need to feed your SOTA fix? Check this out: https://youtu.be/OWKaIjNRBCU
Or do you have other burning regulatory needs? Check out our website: https://leanraqa.com/services/regulatory-strategy/