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 Resources

The FDA’s Action Plan for AI-ML-Based Software As A Medical Device

The FDA’s Action Plan for AI-ML-Based Software As A Medical Device

In this webinar hosted from EMMA International's Software Engineer, Govind Yatnalkar, he focuses on the recently released FDA's action plan for regulating AI/ML-based software as a medical device (SaMD). He then dives into the five major action items provided in the action plan along with examples that define the actual regulation strategies for AI/ML-based SaMDs.
Is Electronic-IFU an Option?

Is Electronic-IFU an Option?

Changes in technology call for changes in the ways we use that technology. This means that the instructions for ...

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