ISO 13485 is the standard published by ISO which is most popularly accepted by medical industries as a standard for quality management system. ISO 13485 certification in Saudi Arabia is proven to be an effective foundation for achieving quality and meet the comprehensive requirements of EU Medical Device Directive (MDD) and the EU Medical Device Regulation (MDR). ISO 13485 adapts the ISO 9001 process-based model for a regulated medical device manufacturing environment
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