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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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Registration of medical devices, active implantable medical devices and procedure packs and kits in the Italian NSIS database. This process is mandatory and independent of the fact that the products already have the CE mark.
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Obtain a Certificate of Free Sale (CFS) for Medical Devices. This document demonstrates that the product can be sold freely in a high medical vigilance zone (EU).
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