Reliability

E&E Medicals will help you carry design reviews to spot any major issues that will create obstacles to compliance testing.

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Six sigma

E&E Medicals offers a very unique Six Sigma program that is designed for the Healthcare industry.

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Ultimate goal

E&E Medicals will help to prepare you very well with the ultimate goal of bringing your organization into compliance with FDA requirements.

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Compliance

The purpose of compliance is to ensure that the provisions of medical devices legislation are complied with after devices are placed on the market.

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ISO certified

E&E Medicals will help you implement processes and procedures that comply with the requirements listed in ISO 13485:2003.

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FDA

E & E Medicals and consulting helps its clients during the process of submitting applications for class I, II, III medical devices at any stage of the product development.

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Quality

E&E Medicals will represent you as your US Agent in assisting communication between the FDA.

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QMS

E&E Medicals Quality management Experts have been developing and implementing quality systems in companies attempting their first products approved by the FDA.

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483 Warning

Medical device or IVD manufacturers will always want to avoid Form 483 or Warning Letter from the US Food and Drug Administration (FDA).

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