?tibar ve imaj geri???: ISO 13485 standard?na uygunluk belgesi, medikal cihaz üreticilerinin kredi?n? ve imaj?n? zaitr?r ve rekabet avantaj? esenlar.External and internal issues, bey well as interested parties, need to be identified and considered. Requirements may include regulatory issues, but they may also go far beyond.Control Objectives and C