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

Clinical

Remediation

Project Management

Staff Augmentation

Mergers & Acquisitions

Ready to learn more about working with us?

Full Circle Consulting Resources

Annual Drug Product Reviews

Annual Drug Product Reviews

If you are a drug manufacturer in the US, an Annual Drug Product Review (ADPR) should be familiar to you. ADPRs ...
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the ...
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration ...

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