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  • E&E Medicals and consulting Post Market Surveillance Experts shall help in coordinating and investigating customer complaints, makes an initial reporting decision, and ensures completeness and consistency of complaint and related documentation. Medical Device Post-marketing .. [more...]

  • ISO 13485 is an international standard adapted to meet the requirements of the medical device industry and it addresses most FDA requirements (21CFR820). E&E Medicals will assist in training, documentation, implementation, internal audit and related services to ensure full compliance.  [more...]

  • E&E Medicals and consulting will help its clients during the process of submitting applications for class I, II, III medical devices at any stage of the product development. Our qualified team of experts will submit FDA medical device regulatory documents for U.S and international clients.  [more...]

  • E&E Medicals will help 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 test plan has two objectives: Repeatability and Survival. [more...]

  • 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 of your individual business and disciplines. [more...]

  • E&E Medicals will help you define your medical device establishment registration requirements and guide through the electronic establishment registration and medical device listing process, which uses the FDA unified registration and listing systems (FURLS)  [more...]

  • The United States Food and Drug Administration (FDA) require all medical device, IVD and pharmaceutical companies not located in the United States to appoint a registered US FDA Agent. E&E Medicals will represent you as your US Agent in assisting communication between the FDA.  [more...]

  • E&E Medicals and consulting Quality management experts develop and implement quality systems in companies attempting their first products approved by the FDA. We help in designing Smart Quality Management Systems that streamline business demands and increase practical time usage.  [more...]

  • Medical device or IVD manufacturers will always want to avoid Form 483 or Warning Letter from the US Food and Drug Administration (FDA). E&E Medicals and consulting shall help in responding to FDA 483 Observations and FDA Warning Letter through corrective actions.  [more...]