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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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Services that we offer for CE marking |
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Preparation
of regulatory strategy for the CE marking
of any new product you wish to develop, manufacture and
eventually export.
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Manufacturer
registration and product listing (CE marking)
of all your medical products with the Regulatory Authorities.
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Adverse
Incident and Recall Reporting of products with CE
marking to the Regulatory Authorities.
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Handling
of customer complaints received through the regulatory
authorities regarding products with CE marking.
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Consultation
services regarding CE marking of any
medical device or laboratory equipment: Regulatory / QA
/ Product Compliance.
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