Diagnostic
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As the regulatory requirements for medical laboratories continue to increase, discover why EMMA International is the leading end-to-end diagnostic and clinical lab 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 lab organization become industry leading.

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Diagnostic Lab Resources

Understanding Biosimilar Products

A Biosimilar is essentially a biologic product that is similar and has no clinically significant difference in terms of safety, purity, and potency from an existing approved Biologic on the market.

The FDA and AI/ML in Medical Devices: Navigating the Future of Healthcare

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing healthcare, offering unprecedented opportunities to improve patient outcomes, streamline processes, and enhance diagnostic accuracy. As AI and ML continue to make significant strides in the medical field, the U.S. Food and Drug Administration (FDA) plays a pivotal role in regulating these innovations. In this blog post, we'll explore the intersection of AI/ML and medical devices, and how the FDA is navigating this rapidly evolving landscape.

The FDA’s Update to Biocompatibility Guidance

The FDA’s guidance document on the use of ISO 10993-1 was updated this month with some crucial information for medical device manufacturers. Biocompatibility testing has been a long-standing requirement for a majority of device manufacturers, so this update that includes some excluded materials and devices is a welcome change.

Mastering the Art of Medical Device Design Controls

Effective design controls are fundamental to producing safe and effective medical devices. They not only help ensure regulatory compliance but also contribute to the overall quality and reliability of the product. Continuous improvement and a commitment to robust design control processes are essential for success in the medical device industry.

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The automotive industry has a vast array of challenges for companies to navigate. Industry trends such as autonomous technology, a focus on electric vehicles, and growing consumer demand can put a strain on your business. EMMA International’s team of experts can provide best-in-class automotive consulting services to drive your company towards excellence.

From product development, compliance to emissions and quality standards, and continuous improvement towards operational excellence, let EMMA International drive your company forward.

We have assisted organizations across the entire automotive supply chain with:

Need more than just a helping hand? We can also provide staff augmentation services to fill any labor gaps in your operation. From product engineers to senior-level positions, and everything in between, EMMA has the right talent at the right time.

Customer demands in the automotive industry are on the rise. Today’s consumers expect more from OEM’s, let EMMA help you exceed their expectations.