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

The 510K Process

The 510K Process

A 510(k) is a premarket submission made to the Food and Drug Administration (FDA) by medical device manufacturers to demonstrate that their device is safe and effective for its intended use. The process is required for devices that are not exempt from premarket notification requirements. This article outlines the steps involved in obtaining a 510(k) clearance.
Quality Through Automation

Quality Through Automation

Whether looking to update an existing process or implement something brand new, process design is a critical ...
EMMA International Consulting Group Celebrates 10 Years of Providing Quality, Regulatory and Compliance Services

EMMA International Consulting Group Celebrates 10 Years of Providing Quality, Regulatory and Compliance Services

Since its inception, EMMA International has been dedicated to providing consulting services to help ensure clients' products advance seamlessly from concept to approval. Throughout this time, the company has continued to grow and expand, solidifying its position as a leader in the field. This growth and success are evident in EMMA International's multiple recognitions on the Inc 5000 list, which highlights the fastest-growing private companies in the United States. The company's unwavering commitment to delivering exceptional services and its ability to adapt to an ever-changing industry have been key to its continued growth and recognition.
Equipment Validation

Equipment Validation

Accurate and precise measurements are vital in the pharmaceutical, medical device, and other FDA regulated ...

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