Manufacturing and DISTRIBUTION 

Consulting

Good Manufacturing Practices (GMP) change frequently. Partnering with a global compliance expert will ensure your manufacturing processes stay in compliance with Current Good Manufacturing Practices (cGMP).

EMMA International helps your organization implement and maintain the appropriate processes to support cGMP compliance for the highest level of product quality, safety, and strength. Backed by decades of cGMP experience, EMMA International has the experts on hand to not only manage your compliance project, but also facilitate manufacturing runs and remediate existing operations.

Contact us to find out how we can help your compliance needs.

Our Medical Device CMO

EMMA International proudly partners with New Concept Technology (NCT), a single-source supplier that offers expert design, engineering, process development, fabrication, and manufacturing services. NCT’s facility has a state-of-the-art class 100K clean room that is ISO 1464-1 Class 8 Certified. NCT is considered an expert in medical assembly. They also specialize in medical cable over-molding and medical process automation.

Ready to discuss your next project? Get in touch.

Ready to learn more about working with us?

Resources

The End of the COVID-19 Public Health Emergency

The End of the COVID-19 Public Health Emergency

After over 3 years, the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023, the Biden Administration announced last week.1After 3.5 years of the modified policy to allow for amore efficient path for COVID-19-related medical products to get to market, this begs the question of how it will impact the MedTech world.
Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
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.

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