Whether you’re an emerging startup with a novel device or an established company with a portfolio of products, EMMA International has a solution to meet your needs.
With decades of industry experience, regulatory and compliance expertise, and a suite of scalable solutions, we’ll help advance your product in accordance with regulatory requirements worldwide.
Medical Device Timeline
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 by doing quality and regulatory work in unison, all while ensuring compliance. 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’s. 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.