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If you want to know more about regulatory issues of Medical
Devices, click here.
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All Non-European manufacturers of medical equipment who wish to market their products in the EU market under their own name must designate a Regulatory Authorized Representative in order to meet CE 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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