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FDA Consultancy

FDA consultancy services | 21 CFR Part 820 | FDA 510(k) process

FDA provides valuable services to ensure that all food is safe; all medical products are safe and effective; and the public health is advanced and protected. Its mission is protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.

Calimex USA is a Medical Device Establishment registered with FDA. Our Registration Number is 3009596585. Our Owner Operator Number is 10040612. We have three software applications registered as medical devices with FDA 510(k) approvals and one registered as a Class I medical device.

Calimex USA provides FDA consultancy services to large international companies world-wide. Services include providing consultancy services on software design, network and infrastructure architecture including mobile devices for EMC, EMI, RF; software quality assurance, cGMP, compliance to 21 CFR Part II, 21 CFR Part 820 and taking their medical devices through the FDA 510(k) processes. The code of federal regulations in 21 CFR is huge. Calimex does not claim to be the expert in every area in this 21 CFR. However we do due diligence to ensure that you are in compliance with the areas we specialize in - i.e. software that are classified as medical devices and medical devices that uses software one way or the other.