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

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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