Tag: "ISO 13485 / MDR certification" - Expert Advice Community



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  • ISO 13485/MDR certification

     We are preparing for the certification according to ISO 13485 and MDR.  Our company has 14 meddev families. Is it possible to limit the scope of the certification on 2 families only or we HAVE to have all 14 families covered (risk file, tech file, etc)? So technically we would use the CE mark on two products initally and move forward.