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\u062a\u0645 \u062a\u0635\u0645\u064a\u0645 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u0634\u0627\u0645\u0644 \u0644\u062f\u064a\u0646\u0627 \u0648\u0635\u064a\u0627\u0646\u062a\u0647 \u0628\u062f\u0642\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0635\u0627\u0631\u0645\u0629 \u0644\u0640 ISO 13485:2016 \u0648ISO 9001:2015\u060c \u0628\u0627\u0644\u0625\u0636\u0627\u0641\u0629 \u0625\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0639\u0627\u0645\u0629 \u0644\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 (SFDA).<br \/>\u064a\u0634\u0645\u0644 \u0647\u0630\u0627 \u0627\u0644\u0646\u0638\u0627\u0645 \u0643\u0627\u0641\u0629 \u062c\u0648\u0627\u0646\u0628 \u0639\u0645\u0644\u064a\u0627\u062a\u0646\u0627\u060c \u0628\u062f\u0621\u064b\u0627 \u0645\u0646 \u0627\u0628\u062a\u0643\u0627\u0631 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\u0627\u0644\u0646\u0638\u0627\u0645 \u0643\u0627\u0641\u0629 \u062c\u0648\u0627\u0646\u0628 \u0639\u0645\u0644\u064a\u0627\u062a\u0646\u0627\u060c \u0628\u062f\u0621\u064b\u0627 \u0645\u0646 \u0627\u0628\u062a\u0643\u0627\u0631 \u0648\u062a\u0637\u0648\u064a\u0631 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a\u060c \u0645\u0631\u0648\u0631\u064b\u0627 \u0628\u0639\u0645\u0644\u064a\u0627\u062a \u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0648\u0627\u0644\u062a\u0648\u0632\u064a\u0639\u060c \u0648\u0648\u0635\u0648\u0644\u0627\u064b \u0625\u0644\u0649 \u062e\u062f\u0645\u0627\u062a \u0627\u0644\u062f\u0639\u0645 \u0645\u0627 \u0628\u0639\u062f \u0627\u0644\u0628\u064a\u0639.\u0648\u064a\u062d\u0631\u0635 \u0641\u0631\u064a\u0642 \u0645\u062a\u062e\u0635\u0635 \u0645\u0646 \u062e\u0628\u0631\u0627\u0621 \u0627\u0644\u062c\u0648\u062f\u0629 \u0648\u0627\u0644\u0628\u0627\u062d\u062b\u064a\u0646 \u0639\u0644\u0649 \u062a\u0637\u0628\u064a\u0642 \u0647\u0630\u0627 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