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Ask Epista: SaMD

Got questions about SaMD, the new regulations, and AI and Machine Learning? Let our experts fill you in.

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.

Do you know how to classify your SaMD under the new MDR regulations?

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!

Good advice and important considerations for SaMD that includes AI or Machine Learning

Join this episode of Ask Epista where our experts discuss AI and ML topics including:

  • Intended use
  • QMS requirements for both EMA and FDA
  • Validation, solution impact, and classification
  • Special characteristics
  • Discuss the domains where AI and ML are used, including current US trends
  • Challenges – what’s the big deal?


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Hanne Harbo Hansen
Principal Consultant
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