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.
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.
Meet submission milestones and develop plans to mitigate challenges with a thorough regulatory strategy.
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.
With hundreds of regulatory submissions to our credit, you can trust EMMA International for accurate, timely 510(K), PMA, and CE Mark 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.
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.