We position our clients at the forefront of their field!

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.

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.

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 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 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.

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.

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.

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.

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.