Case Studies for Proven Expertise and Success

EMMA International has helped many different clients in industries from Medical Device, Pharmaceuticals, Biologics, and everything in between. Using our tried-and-true CLIC™ Methodology, we have successfully implemented quality management systems, remediated after an enforcement action, optimized Quality Systems processes for operational excellence, and so much more.

Curious about how EMMA might be able to help your company? Contact us today and we can send over a case study from our extensive library of past projects so you can learn more about how EMMA could be right for you.

More Resources

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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