The system was certified in accordance with UNI CEI EN ISO 13485:2021, and since then it has been governed by a Quality System in line with the requisites called for in Directive 93/42/EEC for medical devices with regard to design, production and marketing.
Thanks to its thoroughness and precision in the product design stage, the quality level of its production and of the materials used, and to the checks carried out in each of the various stages up to packaging of the product, the company EDIERRE IMPLANT SYSTEM has obtained CE certification.
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