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.

Full Service

Full Circle Consulting

EMMA OnDemand

Quality

Quality System Development

Quality System Implementation

Post Market Compliance

ISO Standards Consulting

Operations

Product Development

Manufacturing & Distribution

Regulatory

Regulatory Strategy

Regulatory Submissions

EU MDR and IVDR

Featured Services

Project Management

Staff Augmentation

Ready to learn more about working with us?

Full Circle Consulting Resources

What to Expect When You’re Inspected

What to Expect When You’re Inspected

In this webinar hosted from EMMA International's Manager of Technical Operations, Madison Wheeler, she gives a walkthrough of what to expect from an FDA inspection of your facility, plus the "do's and don'ts" of regulatory inspections.
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.

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