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Fast transfer of certification
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As the world globalizes, more and more manufacturers of medical devices desire access to the worldwide market. To shorten the time to market, KEMA can offer them one-stop shopping to the European, North American and Taiwanese market.
In order to professionalize services, KEMA has developed a standard program for the transfer of certificates. KEMA offers its new customers one and the same procedure throughout all its four local offices in the eastern and western region of the USA, the Netherlands and Israel. All activities are geared to one another. This speeds up the transfer process and increases customer satisfaction.
Gap analysis
KEMA reviews the existing certificate and reports from their current certification body. KEMA has also to be sure the market data for the product is acceptable and that the company is aware of the safety and performance of their device in the marketplace. A gap analysis is performed between KEMA’s dossier review and the current registrar’s to be sure adequate coverage of key elements are documented. KEMA uses a 2-phase method to transfer the certificates. Phase 1 includes the review of existing certificates and reports. Phase 2 includes the verification assessment on site (audit). The certificates will be issued within two months. Companies that will gain the most from the transfer are those manufacturing high-risk innovative devices with short time to market needs.
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