In Vitro Diagnostics

Advances in genetic sequencing, molecular diagnostics, and at-home tests have generated excitement in the IVD space. However, IVD development also comes with significant regulatory risk. To assure your IVD meets all the necessary standards, partner with a global leader in regulatory, quality, and compliance.

EMMA International provides end-to-end solutions for companies that specialize in diagnostic equipment, molecular analysis, immunoassays, and at-home tests. We develop strong relationships to help you realize a more efficient path to market and higher business value.

Whether you seek FDA clearance, need evidence to satisfy a notified body, or need EU IVDR transition support, EMMA International has the scientific and regulatory experts to help you every step of the way.

IVD Timeline

Product Development

EMMA International plays a strategic role in product development from day one. Our in-house technical and scientific experts provide valuable input to help you meet your business needs, while ensuring compliance, by doing quality and regulatory work in unison. When you’re ready, we’ll be there for strategy and submission.

Learn more about product development.

Regulatory Strategy

Meet submission milestones and develop plans to mitigate challenges with a thorough regulatory strategy.

Learn more about our regulatory strategy.

Clinical Investigations

Regulatory approvals depend on successful clinical trials. We help move your trial to the finish line with study design development support. We also identify and monitor clinical sites and generate clinical investigation reports, among other activities.

Learn more about clinical investigations.

Regulatory Submissions

With hundreds of regulatory submissions to our credit, you can trust EMMA International for accurate, timely 510(K), PMA, and CE Mark submissions.

Learn more about regulatory submissions.

QMS Development and Maintenance

Ensure your quality management system (QMS) suits your organizational structure. Using EMMA International’s proprietary QMS methodology, CLIC™, we develop and implement Compliant, Lean, Integrated, and Customizable QMS. We will maintain any and all aspects of your QMS, from CAPA processes and supplier management activities to regulatory inspections.

Post-Market Surveillance

As you move past clearances and approvals, turn your attention to commercialization and innovation. EMMA International will take care of post-market surveillance and vigilance reporting activities.

Learn more about post-market compliance.


Move your IVD forward with EMMA International. Speak with one of our experts to learn more.

Ready to learn more about working with us?

IVD Resources

Supplier Controls

Supplier Controls

How does a medical device manufacturer make sure that they prevent garbage from coming into their factory, and therefore lessen the ways that garbage can go out?  Supplier controls are a set of useful tools to evaluate potential suppliers for product quality, as well as other important capabilities of suppliers.  It’s not just a good idea, it’s the law, according to 21 CFR 820.50.
EU MDR: Extending the Transition Period for Medical Devices

EU MDR: Extending the Transition Period for Medical Devices

The European Commission has implemented a proposal to extend the transitional period to certify medical devices under the Medical Devices Regulation (MDR). The proposal allows more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation
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.

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