Diagnostic
Labs

As the regulatory requirements for medical laboratories continue to increase, discover why EMMA International is the leading end-to-end diagnostic and clinical laboratory consulting firm.

By partnering with key stakeholders at your lab, EMMA can support your team to navigate even the most complex of challenges and help them capitalize on efficiencies and opportunities.

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Quality Management System Development and Maintenance

Having a robust and compliant QMS is only the first step. EMMA can help you develop your QMS and then maintain it for continued sustainability.

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CLIA Applications and Compliance

Let EMMA handle preparing and managing your CLIA applications and status, so you don’t have to.

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Test Method Validation

No test is too complex for our team of experts. With a wide variety of experience, our team can execute and support the validation of new test methods for your lab to improve your service portfolio.

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Laboratory Management and Staff Augmentation

Don’t let staffing needs impact your business. EMMA International can help fill any staffing gaps to keep your lab running smoothly and successfully.

The laboratory world can be complex, let EMMA help simplify. Reach out to our experts today to explore how we can help your laboratory organization become industry leading.

Ready to learn more about working with us?

Diagnostic Lab Resources

Medical Device PMA

Medical Device PMA

In 1976, the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Acts established three regulatory ...
Types of Regulatory Audits

Types of Regulatory Audits

There are many different types of Regulatory audits that can be conducted. These are audits that upon successful ...
Certificate of Analysis

Certificate of Analysis

A certificate of analysis (CoA) is a document that manufacturers create that verifies the products they ...
When to Pursue Quality

When to Pursue Quality

Quality is something that should be integrated into an organization. To pursue quality means to drive forward ...

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