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

When

Product Development

Regulatory Submissions

Post Market Compliance

Manufacturing and Distribution

Why

Regulatory Strategy

Quality System Development

Quality System Implementation

EMMA OnDemand

Featured Services

COVID-19

EU MDR and IVDR

MDSAP

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Full Circle Consulting Resources

Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.
Managing Risks

Managing Risks

All of life entails some about of risk. The most humans can really do is mitigate the destructive effects of these risks that we take on a daily basis., the same goes with medical devices.
The Significance of Design Controls

The Significance of Design Controls

In the 1980s, the Food & Drug Administration (FDA) studied the causes of voluntary recalls of medical devices. Between October 1983 and September 1989, they found that about forty-four percent of these recalls were due to design issues.
<strong>Paperwork: The Necessary Evil</strong>

Paperwork: The Necessary Evil

No one genuinely enjoys doing paperwork. At best, people may dislike paperwork less than other parts of their jobs. Yet the FDA requires a certain amount of paperwork to document processes and results for the medical devices under their jurisdiction

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