Epista Influencers help the industry with SaMD

Two Epista experts explain the complex world of SaMD

Meet Epista Influencers, Suvi Hänninen, Regional Manager & Principal Consultant, and Hanne Hansen, Principal Consultant. These two work to help Life Science professionals understand the ever-evolving world of Software as a Medical Device (SaMD). Companies in the Life Science industry are constantly being challenged to stay up-to-date with the latest SaMD regulations, especially when it comes to patient safety and regulatory compliance. That means not only understanding, but also being able to apply these changes to their products when necessary. But, how can these companies keep up?

Suvi and Hanne took the time to record a two-part video series where they discuss two key topics about SaMD: the new MDR regulations (specifically rules 9, 10, 11, and 12) and SaMD including AI and/or Machine Learning (ML). In these videos, they dive into details and examine definitions, provide examples, and share their best advice for working with SaMD. Suvi and Hanne have taken a stab at making the world of SaMD just a little bit simpler. Check out the first video, Classifying SaMD under new MDR regulations, here:

For more information on SaMD, watch the second part of the video series, Good Advice and Important Considerations for SaMD involving AI or ML, here.

By sharing their expert knowledge and advice, Suvi and Hanne hope to help others in the Life Sciences garner a better understanding of regulations and technology that are playing major roles in the industry today. If you have questions about SaMD or other regulatory challenges, get in touch. We love to share our knowledge.

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Hanne Harbo Hansen
Principal Consultant

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