Friday, 10 April 2015

Is iso 13485 mandatory

ISO 134, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development . Feb CAN/CSA- ISO 134:0 Medical devices – Quality management systems – Requirements for regulatory. References to ISO 134:20have been added and references to 134:1996/have been. AENOR Spain AFNOR Certification France AIB-Vinçotte International Belgium ANCE-SIGE Mexico APCER Portugal CCC Cyprus. Scope of Certificate: Production of medical implants and instruments. ZERTIFIKAT CERTIFICATE BB EE GEP - CEPTNO UKAT CERTIFICADO . The mdc audit has proven that this quality management system meets all requirements of the following standard.


Was versteht man unter der ISO 134? Die Norm ISO 134trägt den Titel „ Medizinprodukte –. Qualitätsmanagementsysteme – Anforderungen für re-. The latest version of ISO 134was published in 201 and the transition from the previous version is ahead. One of the most important steps in the transition . Apr QUALITY MANAGEMENT SYSTEM - ISO 134:2016. This is to certify that: EUROME Inc.


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