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If you want to know more about regulatory issues of Medical Devices, click here |
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All Non-USA manufacturers of medical equipment who wish to market their products under their own name in the US market must appoint a Regulatory Designated Agent in order to meet FDA requirements. |
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Services that we offer for FDA clearance
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Preparation
of regulatory strategy for FDA clearance
of any new product you wish to develop, manufacture and
eventually export.
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Manufacturer Registration and Product Listing of all your
medical products with FDA.
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Adverse Incident and Recall Reporting to FDA.
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Handling of customer complaints received through FDA.
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Consultation services related to FDA clearance:
regulatory / QA / product compliance of any medical device
or laboratory equipment.
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