Medical Devices

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

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 by doing quality and regulatory work in unison, all while ensuring compliance. When you’re ready, we’ll be there for strategy and submission.

Learn more about product development here.

Regulatory Strategy

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

Learn more about our regulatory consulting.

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’s. 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 medical device forward with EMMA International. Speak with one of our experts to learn more.

Ready to learn more about working with us?

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Medical Device Resources

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.

FDA’s Effort to Modernize the 510(k)

The 510k program is by far the most popular medical device pathway, and as MedTech has continued to modernize and innovate, so should the 510k program. Earlier this month, the FDA announced the steps it was taking to modernize the 510k program, a much sought after initiative that the industry has been asking for.

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