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.

R

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.

R

CLIA Applications and Compliance

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

R

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.

R

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

Intended Use Validation

Intended Use Validation

Medical Device Manufacturers in the United States have to comply with intended use validation (IUV) requirements. ...
Design Outputs

Design Outputs

Part of the design process is the development of what is known as Design Outputs. According to the FDA “Design ...
Regulation and Labeling

Regulation and Labeling

Complying with all regulatory requirements for a regulated product is a massive challenge. Meeting all labeling ...

Pin It on Pinterest