QUALITY ASSURANCE: STANDARDS,QUALITY CONTROL PROCESSES, CERTIFICATES.

 Tecno Breast mammary implants have obtained the CE certificate for class III medical devices in the European Union (directive 93/42/CEE) and they are produced by a quality control system according to international standards for medical devices required by standards EN ISO 9001 and EN ISO 13485. All the primary materials which make up the prostheses are silicon medical grade and are designed and tested to satisfy ISO 10993 biocompatibility requisites.     menù