EMMA International- The Speed You Need When You Need Support FAST!

by | Sep 30, 2021 | Compliance, Consulting Group, Data, EU, EU MDR, FDA, ISO, MedTech, Pharmaceuticals, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardization, Standards


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In today’s world of social media, we blast our wins and hide behind our dirty laundry.  No one is going to post on their LinkedIn feed, ‘have a huge backlog of CAPA’s, our QMS is non-compliant, and we are scared if the FDA walks through our front door’.

But what happens when you can no longer hide your dirty laundry? You need help fast and your first call needs to be to EMMA International because yes, a human will answer and you will not get caught in a, “press 1, press 2 nightmare”.

But all jokes aside, EMMA International can help you solve your quality and compliance needs with unparallel speed. We do this by utilizing a hybrid model of internal personnel and consultant partnerships that can provide emergency resourcing within hours. That means we can start helping you the same day you call us. Many of our peers need days to start recruiting contractors that they 1) have never worked with before and 2) will start bill for contractors prior to having a strategic plan to solve your problem.  This is a recipe for disaster and can leave you feeling that you added more chaos and cost to your problems and no closer to a solution. 

Whether you need a smaller limited assignment or a long-term complex project, EMMA International’s experienced regulatoryquality, and compliance experts are here to help. Our expertise extends from United States and international regulatory requirements to MDSAP, ISO, and GCP standards. Give us a call at 248-987-4497 or email info@emmainternational.com to get connected with us today!

Kira Jabri

Kira Jabri

Kira Jabri, MPH, MSW, PMP is the COO of EMMA International Consulting Group, Inc. She is responsible for designing and implementing EMMA International’s business operations, marketing, and strategy. Mrs. Jabri has over twenty years of experience as a healthcare professional and is an industry expert in company culture and diversity, organizational behavior management, organizational leadership, business strategy development, and contemporary challenges in business. Mrs. Jabri holds a Master of Public Health from Walden University, a Master of Social Work from Columbia University and Bachelor of Arts degrees in Social Work and Psychology from Cedar Crest College.

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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