Life Science companies are challenged to reconcile the ever-evolving world of SaMD (Software as a Medical Device) with patient safety and regulatory compliance. We’ve put together some expert advice for you.
In this episode, our experts examine the definition of SaMD and intended use. They drill down into the decision tree to help you determine the correct classification for your SaMD, including an examination of rules 9, 10 and 11. They also discuss the differences between FDA and EMA when it comes to definition and classification of SaMD. And, they address where the NBs fit into the picture. Enjoy this information packed episode of Ask Epista!
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