Full Circle Consulting

EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.

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Full Circle Consulting


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Full Circle Consulting Resources

AI and ML in Software as a Medical Device

AI and ML in Software as a Medical Device

In this webinar, we will be covering what exactly an SaMDs, or Software as a Medical Device, and go over some examples with Artificial Intelligence. We will also look at Artificial Intelligence and Machine Learning versus the traditional software. Next, we will go into the regulatory framework for these types of software, then explain how EMMA International can help you get your SaMD to market.
Building a QMS for Your SaMD – Part II

Building a QMS for Your SaMD – Part II

In this second part of the webinar, we will review how to tackle changes that were made to the software post market, the verification and validation activities for your software, regulatory clearance of changes made to the software post market, and how to handle software recalls.

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