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 System Development

Quality System Implementation

Post Market Compliance

ISO Standards Consulting


Product Development

Manufacturing & Distribution


Regulatory Strategy

Regulatory Submissions


Featured Services

Project Management

Staff Augmentation

Ready to learn more about working with us?

Full Circle Consulting Resources

FDA Fundamentals: Understanding the 513(g)

FDA Fundamentals: Understanding the 513(g)

In this blog, we will explore into the intricacies of the 513(g) process, its significance, and how it aids innovators in achieving regulatory approval for their medical devices.
EU IVDR: A Comprehensive Guide

EU IVDR: A Comprehensive Guide

In the landscape of global medical device regulation, the European Union In Vitro Diagnostic Regulation (EU IVDR) stands as a significant milestone. Introduced to enhance patient safety and streamline market access for in vitro diagnostic (IVD) devices, the EU IVDR replaces the previous In Vitro Diagnostic Directive (IVDD) and brings with it a host of changes that impact manufacturers, notified bodies, and other stakeholders in the healthcare industry.

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