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?

Medical Device Resources

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.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.
Benefits of a QMS

Benefits of a QMS

Many companies do not understand the benefits of having a structured Quality Management System (QMS). A QMS is a system that documents procedures, processes, and responsibilities to achieve quality objectives and policies1. Quality management systems can be utilized in many industries especially the pharmaceutical and medical device industries, to provide structure for all processes at a facility.

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