At EMMA International, we constantly work in a fast-paced environment, which means we are team-centric and work hard to achieve collective goals and ensure client success. We recently went around the office and asked several employees what their favorite thing about working for EMMA International was. While there were various responses, they mainly focused on the culture.

Nofal Paulus, our business development specialist, stated he enjoyed the team harmony that exists within the company and the positive work environment. He said, “I enjoy the challenges I am presented with and the opportunity to learn and expand my experience continuously.”

Our Technical Team focused more on the work we do. The overall consensus was they enjoy the wide range of projects we work on and the opportunity to be involved in so many different industries. The uniqueness of each project, the challenges they present, and the ability to work through those challenges and help our clients worldwide.

Technical Writer, Alexis Ferrier, described that she enjoys working here because of the work environment. Our clients face many challenges, and while their road to success is not always smooth sailing, she appreciates that we collaborate and ask questions to ensure we are doing our best.

Jennifer Silich, our executive assistant, said “I enjoy that we have such a great teamwork culture here. We all work together to help each other and collaborate. I love how much everyone matters, no matter the role and how growth is always encouraged.”  

The collaborative efforts on all deliverables helps ensure a high quality of work. We love what we do here at EMMA International to help our clients with quality and regulatory compliance needs. For more information on how we can assist your company, contact us today by phone at 248-987-4497 or email us at info@emmainternational.com.

Emma International

Emma International

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
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.

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