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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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Latest News
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Updated FDA’s Fees for 2008
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IEC released the 3rd edition of IEC 60601-1, a major leap forward in safety and performance of electrical medical devices
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New Standard for Medical Devices Software was released:
IEC 62304:2006 – Medical Device Software – Software Life Cycle Processes.
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