CE & ISO Medical |
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 CE Medical markCefaly bears the CE Medical mark. Independent official bodies have checked that it complies strictly with the European directive applicable to medical devices, namely 93/42 EEC. As part of its ISO Medical certification process, STX-Med has implemented a monitoring system. This system reports that tens of millions of Cefaly devices have been in regular use for several years and not a single incident has been reported. ISO Medical certification STX-Med, the company that designed and produces Cefaly, is ISO-certified. The design, development and production processes comply with the strictest quality standards. ISO Medical 13485: 2003 (quality system specific to medical material) ISO 9001: 2000 (complete quality system) |