Best CE mark approval for medical devices consultants
The CE marking (known as CE mark) is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA).
Biologics License Application (BLA)
Pre-submission and strategic guidance in determining the best route for BLA submission to regulators..
Chemistry, Manufacturing, and Control
E&E Medicals, a leading player in centralized Chemistry, Manufacturing and Controls (CMC) lifecycle management for Regulatory submissions, offers services for CMC Regulatory affairs.
New Drug Application
Help before submitting to the US Food and Drug Administration, including putting together a briefing package and attending a meeting to discuss scientific issues.
US FDA 510(k) Consultants
We prepare and submit FDA medical device regulatory documents and class I, II and III medical devices for the U.S and international clients.
Professional Quality & Regulatory Affairs
Professional Quality & Regulatory Affairs
Our experts solve critical and complex problems of our clients
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US FDA 510(k) Consultants
We prepare and submit FDA medical device regulatory documents and class I, II and III medical devices for the U.S and international clients.
Edit Content
New Drug Application
Help before submitting to the US Food and Drug Administration, including putting together a briefing package and attending a meeting to discuss scientific issues.
Edit Content
Chemistry, Manufacturing, and Control
E&E Medicals, a leading player in centralized Chemistry, Manufacturing and Controls (CMC) lifecycle management for Regulatory submissions, offers services for CMC Regulatory affairs.
Edit Content
Biologics License Application (BLA)
Pre-submission and strategic guidance in determining the best route for BLA submission to regulators..
Services
We position our clients at the forefront of their field!
E&E Medicals helps you carry design reviews to spot any major issues that will create obstacles to compliance testing. Our reliability experts design a test plan for you that ensures your design will last to your expectations in the real world.
E&E Medicals offers a very unique Six Sigma program that is designed for the Healthcare industry. It is based on the DMAIC model - Define, Measure, Analyze, Improve, and Control. We fully customize each application to meet the challenges.
ISO 13485 is an international standard adapted to meet the requirements of the medical device industry and it addresses most FDA requirements (21CFR820). We assist in the end-to-end processes to ensure full compliance.
E&E Medicals helps define the medical device establishment registration requirements, guide through the electronic establishment registration and medical device listing process, which uses the FURLS.
The United States FDA require all medical devices, IVD and pharmaceutical companies not located in the United States to appoint a registered US FDA Agent. E&E Medicals shall represent as US Agent in assisting communication.
Our expert's review device design, risk analysis, clinical evaluation, testing reports, post-market surveillance, labeling, and other required areas. Gap analysis is carried out to ease the transition in the required areas.
The quality management experts at E&E Medicals develop and implement quality systems for companies approved by FDA. We help in designing smart Quality Management Systems that streamline business demands.
E&E Medicals assist during the process of submitting applications for class I, II, III medical devices. Our qualified team of experts shall submit FDA medical device regulatory documents for U.S. and international clients.
Medical device or IVD manufacturers want to avoid Form 483 or Warning Letter from the US Food and Drug Administration. We help in responding to FDA 483 Observations and Warning Letters through corrective actions.
We have over 32 years experience
We have well-established partners in the EU, Asia, and USA. Our customers not only consider us as consultants but also as outsourcing partners for various services.
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Successful Projects
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FDA Regulatory Experts
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FDA 510(k) Submissions
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ISO 13485 Implementations
Contact us
We’d love to hear from you!
Location:
400 Galleria Pkwy Suite 1500
Atlanta, GA 30339
Atlanta, GA 30339
Get in touch:
info@eemedicals.com
Let's talk:
Phone: +1-678-385-6106
Toll-free: (800)-305-6069
Toll-free: (800)-305-6069
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