{"id":2491,"date":"2025-05-01T16:00:40","date_gmt":"2025-05-01T14:00:40","guid":{"rendered":"https:\/\/hsi-eg.co\/?p=2491"},"modified":"2025-04-20T14:58:52","modified_gmt":"2025-04-20T12:58:52","slug":"understanding-ce-marking-for-medical-devices","status":"publish","type":"post","link":"https:\/\/hsi-eg.co\/ar\/understanding-ce-marking-for-medical-devices\/","title":{"rendered":"\u0641\u0647\u0645 \u0639\u0644\u0627\u0645\u0629 CE \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 | \u062f\u0644\u064a\u0644 \u0644\u0644\u0645\u0628\u062a\u062f\u0626\u064a\u0646"},"content":{"rendered":"<p>\u064a\u062a\u0637\u0644\u0628 \u0628\u064a\u0639 \u0648\u062a\u0633\u0648\u064a\u0642 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0641\u064a \u062f\u0648\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a (EU) \u0623\u0646 \u062a\u062d\u0645\u0644 \u0639\u0644\u0627\u0645\u0629 CE 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\u0627\u0644\u0627\u0642\u062a\u0635\u0627\u062f\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629.<\/p>\n<p><strong>\u0648\u0641\u064a\u0645\u0627 \u064a\u0644\u064a \u0628\u0639\u0636 \u0627\u0644\u0641\u0648\u0627\u0626\u062f \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 \u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0639\u0644\u0627\u0645\u0629 CE:<\/strong><\/p>\n<ul>\n<li>\u062a\u0634\u064a\u0631 \u0625\u0644\u0649 \u0623\u0646 \u062c\u0647\u0627\u0632\u0643 \u064a\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 \u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0642\u0627\u0646\u0648\u0646\u064a\u0629 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629 \u0641\u064a \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a.<\/li>\n<li>\u064a\u0633\u0645\u062d \u0628\u0627\u0644\u062a\u0633\u0648\u064a\u0642 \u0641\u064a \u062c\u0645\u064a\u0639 \u0627\u0644\u062f\u0648\u0644 \u0627\u0644\u0640 30 \u0627\u0644\u0623\u0639\u0636\u0627\u0621 \u0641\u064a \u0627\u0644\u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0627\u0642\u062a\u0635\u0627\u062f\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629.<\/li>\n<li>\u0628\u0639\u0636 \u0627\u0644\u062f\u0648\u0644 \u062e\u0627\u0631\u062c \u0627\u0644\u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0627\u0642\u062a\u0635\u0627\u062f\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u062a\u0642\u0628\u0644 \u0639\u0644\u0627\u0645\u0629 CE\u060c \u0645\u0645\u0627 \u064a\u0639\u062f \u0645\u064a\u0632\u0629 \u0639\u0646\u062f \u062f\u062e\u0648\u0644 \u0623\u0633\u0648\u0627\u0642 \u062c\u062f\u064a\u062f\u0629.<\/li>\n<li>\u062a\u0634\u064a\u0631 \u0625\u0644\u0649 \u0623\u0646 \u062c\u0647\u0627\u0632\u0643 \u064a\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 \u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u062c\u0648\u062f\u0629.<\/li>\n<\/ul>\n<h2>\u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0648\u0627\u0644\u062a\u0634\u0631\u064a\u0639\u0627\u062a \u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 CE marking<\/h2>\n<p>\u0645\u0646 \u0627\u0644\u0636\u0631\u0648\u0631\u064a \u0645\u0639\u0631\u0641\u0629 \u0627\u0644\u0644\u0648\u0627\u0626\u062d \u0648\u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0645\u062a\u0639\u0644\u0642\u0629 \u0628\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u0644\u0630\u0644\u0643 \u0633\u0648\u0641 \u0646\u0641\u0635\u0644 \u0623\u0647\u0645 \u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u062f\u0648\u0644\u064a\u0629 \u0648\u0627\u0644\u062a\u0634\u0631\u064a\u0639\u0627\u062a \u0627\u0644\u062a\u064a \u064a\u062c\u0628 \u0623\u0646 \u062a\u0639\u0631\u0641\u0647\u0627 \u0644\u0641\u0647\u0645 \u0623\u0641\u0636\u0644 \u0644\u0643\u064a\u0641\u064a\u0629 \u0639\u0645\u0644 \u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0639\u0644\u0627\u0645\u0629 CE.<\/p>\n<h3>1- \u0627\u0644\u0644\u0627\u0626\u062d\u0629 (EU) 2017\/745<\/h3>\n<p>\u0627\u0644\u0644\u0627\u0626\u062d\u0629 Regulation EU 2017\/745\u060c \u0648\u0627\u0644\u0645\u0639\u0631\u0648\u0641\u0629 \u0623\u064a\u0636\u064b\u0627 \u0628\u0627\u0633\u0645 \u0627\u0644\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0623\u0648 MDR\u060c \u0647\u064a \u0627\u0644\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u062d\u0627\u0644\u064a\u0629 \u0627\u0644\u062a\u064a \u062a\u062d\u0644 \u0645\u062d\u0644 \u0627\u0644\u062a\u0648\u062c\u064a\u0647 \u0627\u0644\u0633\u0627\u0628\u0642 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (MDD) \u0648\u062a\u0648\u062c\u064a\u0647 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u0632\u0631\u0639 \u0627\u0644\u0646\u0634\u0637\u0629 (AIMD) \u0628\u0634\u0643\u0644 \u0643\u0627\u0645\u0644.<\/p>\n<h3>2- \u0627\u0644\u062a\u0648\u062c\u064a\u0647 2001\/83\/EC<\/h3>\n<p>\u0627\u0644\u062a\u0648\u062c\u064a\u0647 Directive 2001\/83\/EC \u064a\u062a\u0639\u0644\u0642 \u0628\u0648\u0636\u0639 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0637\u0628\u064a\u0629 \u0644\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0628\u0634\u0631\u064a \u0641\u064a \u0627\u0644\u0633\u0648\u0642\u060c \u0639\u0646\u062f\u0645\u0627 \u064a\u062a\u0645 \u062f\u0645\u062c \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0645\u0639 \u0645\u0646\u062a\u062c \u062f\u0648\u0627\u0626\u064a\u060c \u0645\u062b\u0644 \u0627\u0644\u062f\u0648\u0627\u0621\u060c \u064a\u062d\u062a\u0627\u062c \u0627\u0644\u0645\u0635\u0646\u0639\u0648\u0646 \u0625\u0644\u0649 \u062a\u062d\u062f\u064a\u062f \u0627\u0644\u062c\u0632\u0621 \u0645\u0646 \u0627\u0644\u0645\u0646\u062a\u062c \u0627\u0644\u0645\u062f\u0645\u062c \u0627\u0644\u0645\u0633\u0624\u0648\u0644 \u0639\u0646 \u0627\u0644\u0646\u0634\u0627\u0637 \u0627\u0644\u0631\u0626\u064a\u0633\u064a \u0644\u0647.<\/p>\n<p>\u0625\u0630\u0627 \u0643\u0627\u0646 \u0627\u0644\u062f\u0648\u0627\u0621 \u064a\u0633\u0627\u0639\u062f \u0641\u064a \u062a\u062d\u0633\u064a\u0646 \u0646\u0634\u0627\u0637 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0637\u0628\u064a \u0648\u0644\u0627 \u064a\u0645\u0643\u0646 \u0627\u0633\u062a\u062e\u062f\u0627\u0645\u0647 \u0628\u0645\u0641\u0631\u062f\u0647\u060c \u0641\u0625\u0646\u0647 \u064a\u0635\u0628\u062d \u062c\u0632\u0621\u064b\u0627 \u0644\u0627 \u064a\u062a\u062c\u0632\u0623 \u0645\u0646 \u0627\u0644\u062c\u0647\u0627\u0632. \u064a\u064f\u0639\u062a\u0628\u0631 \u0627\u0644\u0645\u0646\u062a\u062c \u0627\u0644\u0645\u062f\u0645\u062c \u062c\u0647\u0627\u0632\u064b\u0627 \u0637\u0628\u064a\u064b\u0627 \u0648\u064a\u062c\u0628 \u0623\u0646 \u064a\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 \u0627\u0644\u0644\u0627\u0626\u062d\u0629 EU 2017\/745.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-2531\" src=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/Understanding-CE-Marking-for-Medical-Devices.webp\" alt=\"Understanding CE Marking for Medical Devices\" width=\"1640\" height=\"924\" srcset=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/Understanding-CE-Marking-for-Medical-Devices.webp 1640w, https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/Understanding-CE-Marking-for-Medical-Devices-1278x720.webp 1278w, https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/Understanding-CE-Marking-for-Medical-Devices-768x433.webp 768w, https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/Understanding-CE-Marking-for-Medical-Devices-1536x865.webp 1536w\" sizes=\"auto, (max-width: 1640px) 100vw, 1640px\" \/><\/p>\n<h3>3- \u0627\u0644\u0644\u0627\u0626\u062d\u0629 (EC) 276\/2004<\/h3>\n<p>\u0627\u0644\u0644\u0627\u0626\u062d\u0629 EC 276\/2004 \u062a\u062a\u0639\u0644\u0642 \u0628\u0648\u0636\u0639 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0637\u0628\u064a\u0629 \u0644\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0628\u0634\u0631\u064a \u0648\u0627\u0644\u0628\u064a\u0637\u0631\u064a \u0641\u064a \u0627\u0644\u0633\u0648\u0642\u060c \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u062a\u0639\u0645\u0644 \u0628\u0646\u0641\u0633 \u0627\u0644\u0637\u0631\u064a\u0642\u0629 \u0627\u0644\u062a\u064a \u064a\u0639\u0645\u0644 \u0628\u0647\u0627 \u0627\u0644\u062a\u0648\u062c\u064a\u0647 2001\/83\/EC.<\/p>\n<h3>4- \u0627\u0644\u062a\u0648\u062c\u064a\u0647 2004\/23\/EC<\/h3>\n<p>\u0627\u0644\u062a\u0648\u062c\u064a\u0647 2004\/23\/EC \u064a\u062d\u062f\u062f \u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u062c\u0648\u062f\u0629 \u0648\u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0644\u0644\u062a\u0628\u0631\u0639\u060c \u0648\u0627\u0644\u062a\u0648\u0631\u064a\u062f\u060c \u0648\u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u060c \u0648\u0627\u0644\u0645\u0639\u0627\u0644\u062c\u0629\u060c \u0648\u0627\u0644\u062d\u0641\u0638\u060c \u0648\u0627\u0644\u062a\u062e\u0632\u064a\u0646\u060c \u0648\u0627\u0644\u062a\u0648\u0632\u064a\u0639 \u0644\u0644\u0623\u0646\u0633\u062c\u0629 \u0648\u0627\u0644\u062e\u0644\u0627\u064a\u0627 \u0627\u0644\u0628\u0634\u0631\u064a\u0629\u060c \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u062a\u064a \u062a\u062d\u062a\u0648\u064a \u0639\u0644\u0649 \u0623\u0646\u0633\u062c\u0629 \u0623\u0648 \u062e\u0644\u0627\u064a\u0627 \u063a\u064a\u0631 \u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u062d\u064a\u0627\u0629 \u0648\u0627\u0644\u062a\u064a \u0644\u0647\u0627 \u0646\u0634\u0627\u0637 \u062b\u0627\u0646\u0648\u064a \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0640 MDR.<\/p>\n<p>\u064a\u062c\u0628 \u062a\u0637\u0628\u064a\u0642 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0623\u062f\u0627\u0621 \u0627\u0644\u0639\u0627\u0645\u0629 \u0641\u064a MDR \u0639\u0644\u0649 \u0627\u0644\u062c\u0632\u0621 \u0645\u0646 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0630\u064a \u064a\u062d\u062a\u0648\u064a \u0639\u0644\u0649 \u0647\u0630\u0647 \u0627\u0644\u0639\u0646\u0627\u0635\u0631\u060c \u0628\u063a\u0636 \u0627\u0644\u0646\u0638\u0631 \u0639\u0646 \u0646\u0634\u0627\u0637\u0647\u0627 \u0627\u0644\u0631\u0626\u064a\u0633\u064a.<\/p>\n<h3>5- ISO 13485:2016<\/h3>\n<p>\u062a\u062d\u062f\u062f \u0645\u0639\u064a\u0627\u0631 ISO 13485:2016 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c\u00a0\u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0627 \u064a\u0644\u062a\u0632\u0645 \u0645\u0635\u0646\u0639\u0648 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0628\u0647\u0630\u0627 \u0627\u0644\u0645\u0639\u064a\u0627\u0631\u060c \u062d\u064a\u062b \u0623\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0647 \u064a\u0641\u062a\u0631\u0636 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0641\u064a MDR.<\/p>\n<p>\u064a\u0634\u064a\u0631 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0647\u0630\u0627 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0625\u0644\u0649 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629\u060c \u0645\u062b\u0644:<\/p>\n<ul>\n<li>\u0627\u0644\u062f\u0644\u064a\u0644 \u0627\u0644\u062e\u0627\u0635 \u0628\u0627\u0644\u062c\u0648\u062f\u0629<\/li>\n<li>\u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0648\u0627\u0644\u0633\u062c\u0644\u0627\u062a<\/li>\n<li>\u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629<\/li>\n<li>\u0627\u0644\u0645\u0648\u0627\u0631\u062f \u0627\u0644\u0628\u0634\u0631\u064a\u0629<\/li>\n<li>\u0628\u0646\u064a\u0629 \u0627\u0644\u0645\u0635\u0646\u0639<\/li>\n<li>\u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0627\u0644\u062a\u0644\u0648\u062b<\/li>\n<li>\u062a\u062e\u0637\u064a\u0637 \u0627\u0644\u062a\u0635\u0645\u064a\u0645 \u0648\u0627\u0644\u062a\u0637\u0648\u064a\u0631 \u0648\u0627\u0644\u0646\u0642\u0644\u060c<\/li>\n<li>\u0645\u0644\u0641\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/li>\n<li>\u062a\u0642\u064a\u064a\u0645 \u0648\u0627\u062e\u062a\u064a\u0627\u0631 \u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646<\/li>\n<li>\u0627\u0644\u0623\u0646\u0634\u0637\u0629 \u0627\u0644\u062e\u062f\u0645\u064a\u0629<\/li>\n<li>\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0645\u0639\u0642\u0645\u0629<\/li>\n<li>\u062a\u062d\u062f\u064a\u062f \u0648\u062a\u0639\u0642\u0628 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/li>\n<li>\u0627\u0644\u062a\u0639\u0627\u0645\u0644 \u0645\u0639 \u0627\u0644\u0634\u0643\u0627\u0648\u0649<\/li>\n<li>\u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u063a\u064a\u0631 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629<\/li>\n<li>\u0627\u0644\u0645\u0631\u0627\u0642\u0628\u0629 \u0628\u0639\u062f \u0627\u0644\u0628\u064a\u0639<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-2535\" src=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/ISO-13485-2016.png\" alt=\"ISO 13485-2016\" width=\"1200\" height=\"675\" srcset=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/ISO-13485-2016.png 1200w, https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/ISO-13485-2016-768x432.png 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/p>\n<h3>6- ISO 14971:2019<\/h3>\n<p>\u062a\u0645 \u062a\u0637\u0648\u064a\u0631 ISO 14971:2019 \u062e\u0635\u064a\u0635\u064b\u0627 \u0644\u0644\u0645\u0635\u0646\u0639\u064a\u0646 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0633\u062a\u0646\u0627\u062f\u064b\u0627 \u0625\u0644\u0649 \u0645\u0628\u0627\u062f\u0626 \u062a\u0637\u0628\u064a\u0642 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0639\u0644\u0649 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0648\u064a\u0645\u0643\u0646 \u0627\u0633\u062a\u062e\u062f\u0627\u0645\u0647 \u0643\u062f\u0644\u064a\u0644 \u0641\u064a \u062a\u0637\u0648\u064a\u0631 \u0648\u0635\u064a\u0627\u0646\u0629 \u0627\u0644\u0639\u0645\u0644\u064a\u0627\u062a.<\/p>\n<p>\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0647\u064a \u0645\u0637\u0644\u0628 \u0641\u064a MDR. \u0648\u0645\u0639 \u0630\u0644\u0643\u060c \u064a\u0645\u0643\u0646 \u0644\u0644\u0645\u0635\u0646\u0639\u064a\u0646 \u062a\u062d\u0642\u064a\u0642 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u062f\u0648\u0646 \u0627\u0644\u062d\u0627\u062c\u0629 \u0625\u0644\u0649 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 \u0645\u0646 \u0647\u0630\u0627 \u0627\u0644\u0645\u0639\u064a\u0627\u0631.<\/p>\n<h3>7- FDA 21 CRF \u0627\u0644\u062c\u0632\u0621 820<\/h3>\n<p>\u062a\u062d\u062f\u062f FDA 21 CRF \u0627\u0644\u062c\u0632\u0621 820 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0646\u0638\u0627\u0645 \u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u0645\u0639\u0645\u0648\u0644 \u0628\u0647\u0627 \u0644\u0644\u0645\u0635\u0646\u0639\u064a\u0646 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u064a\u062c\u0628 \u0639\u0644\u0649 \u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u062a\u064a \u062a\u0633\u062a\u0647\u062f\u0641 \u0627\u0644\u0633\u0648\u0642 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a \u0623\u0646 \u062a\u0645\u062a\u0644\u0643 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u062c\u0648\u062f\u0629 \u064a\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 FDA 21 CFR \u0627\u0644\u062c\u0632\u0621 820 \u0648\u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0645\u0646 FDA\u060c \u064a\u0645\u0643\u0646 \u0623\u0646 \u064a\u0643\u0648\u0646 \u0647\u0630\u0627 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0628\u0645\u062b\u0627\u0628\u0629 \u062f\u0644\u064a\u0644 \u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0641\u064a MDR \u0641\u064a \u0627\u0644\u0633\u0648\u0642 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a. \u0648\u0645\u0639 \u0630\u0644\u0643\u060c \u062a\u062e\u062a\u0627\u0631 \u0645\u0639\u0638\u0645 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u062a\u0628\u0627\u0639 \u0645\u0639\u064a\u0627\u0631 ISO 13485:2016\u060c \u0644\u0623\u0646\u0647 \u064a\u0645\u0643\u0646 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 \u0644\u0647.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-2539\" src=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/FDA-21-CFR-Part-820.jpg\" alt=\"FDA 21 CFR Part 820\" width=\"1280\" height=\"720\" srcset=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/FDA-21-CFR-Part-820.jpg 1280w, https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/FDA-21-CFR-Part-820-768x432.jpg 768w\" sizes=\"auto, (max-width: 1280px) 100vw, 1280px\" \/><\/p>\n<h2>\u062e\u0637\u0648\u0627\u062a \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0639\u0644\u0627\u0645\u0629 CE \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u061f<\/h2>\n<p>\u064a\u0645\u0643\u0646 \u0623\u0646 \u062a\u0643\u0648\u0646 \u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0639\u0644\u0627\u0645\u0629 CE \u0645\u0639\u0642\u062f\u0629 \u0625\u0644\u0649 \u062d\u062f \u0645\u0627\u060c \u0644\u0630\u0644\u0643 \u0644\u0645\u0633\u0627\u0639\u062f\u062a\u0643 \u0641\u064a\u060c \u0633\u064a\u0639\u0631\u0636 \u0647\u0630\u0627 \u0627\u0644\u062f\u0644\u064a\u0644 \u0627\u0644\u062e\u0637\u0648\u0627\u062a \u0627\u0644\u0639\u0627\u0645\u0629 \u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u064a\u0647\u0627.<\/p>\n<h3>1. \u062a\u062d\u062f\u064a\u062f \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0637\u0628\u064a<\/h3>\n<p>\u062d\u062f\u062f \u0627\u0644\u062a\u0648\u062c\u064a\u0647\u0627\u062a \u0627\u0644\u062a\u064a \u0648\u0636\u0639\u062a\u0647\u0627 MDR \u0644\u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0628\u0646\u0627\u0621\u064b \u0639\u0644\u0649 \u0645\u0633\u062a\u0648\u0649 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u0648\u0627\u0644\u0645\u0648\u0642\u0639 \u0639\u0644\u0649 \u0627\u0644\u062c\u0633\u0645\u060c \u0648\u0645\u062f\u0629 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645.<\/p>\n<ul>\n<li><strong>\u0627\u0644\u0645\u062e\u0627\u0637\u0631:<\/strong> \u062a\u0646\u0642\u0633\u0645 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0625\u0644\u0649 \u0627\u0644\u0641\u0626\u0627\u062a I \u0648 IIa \u0648 IIb \u0648 III\u060c \u0643\u0644\u0645\u0627 \u0632\u0627\u062f\u062a \u0627\u0644\u0641\u0626\u0629\u060c \u0632\u0627\u062f\u062a \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0627\u0644\u062a\u064a \u064a\u0645\u062b\u0644\u0647\u0627 \u0627\u0644\u062c\u0647\u0627\u0632 \u0644\u0644\u0645\u0631\u064a\u0636.<\/li>\n<li><strong>\u0648\u0636\u0639 \u0627\u0644\u062c\u0647\u0627\u0632 \u0639\u0644\u0649 \u0627\u0644\u062c\u0633\u0645:<\/strong> \u064a\u0645\u0643\u0646 \u0623\u0646 \u062a\u0643\u0648\u0646 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u063a\u064a\u0631 \u062c\u0631\u0627\u062d\u064a\u0629 \u0639\u0646\u062f\u0645\u0627 \u062a\u0643\u0648\u0646 \u0639\u0644\u0649 \u0633\u0637\u062d \u0627\u0644\u062c\u0633\u0645 \u0648\u062c\u0631\u0627\u062d\u064a\u0629 \u0639\u0646\u062f\u0645\u0627 \u062a\u062e\u062a\u0631\u0642 \u0627\u0644\u062c\u0633\u0645.<\/li>\n<li><strong>\u0645\u062f\u0629 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645:<\/strong> \u062a\u062e\u062a\u0644\u0641 \u0645\u062f\u0629 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0623\u064a\u0636\u064b\u0627\u060c \u062d\u064a\u062b \u064a\u062a\u0645 \u062a\u062d\u062f\u064a\u062f\u0647\u0627 \u0643\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0639\u0627\u0628\u0631 \u064a\u0635\u0644 \u0625\u0644\u0649 60 \u062f\u0642\u064a\u0642\u0629\u060c \u0623\u0648 \u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0642\u0635\u064a\u0631 \u0627\u0644\u0623\u0645\u062f \u064a\u0635\u0644 \u0625\u0644\u0649 30 \u064a\u0648\u0645\u064b\u0627\u060c \u0648\u0625\u0630\u0627 \u062a\u062c\u0627\u0648\u0632\u062a \u0647\u0630\u0647 \u0627\u0644\u0641\u062a\u0631\u0629\u060c \u0641\u0625\u0646\u0647\u0627 \u062a\u0635\u0628\u062d \u062c\u0647\u0627\u0632\u064b\u0627 \u0644\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0637\u0648\u064a\u0644 \u0627\u0644\u0623\u0645\u062f.<\/li>\n<\/ul>\n<h3>2. \u062a\u0639\u064a\u064a\u0646 \u0634\u062e\u0635 \u0645\u0633\u0624\u0648\u0644 \u0639\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a<\/h3>\n<p>\u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0623\u0646 \u064a\u0643\u0648\u0646 \u0644\u062f\u064a\u0647\u0627 \u0634\u062e\u0635 \u0648\u0627\u062d\u062f \u0639\u0644\u0649 \u0627\u0644\u0623\u0642\u0644 \u0645\u0633\u0624\u0648\u0644 \u0639\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a \u062f\u0627\u062e\u0644 \u0627\u0644\u0634\u0631\u0643\u0629\u060c \u0648\u064a\u062c\u0628 \u0623\u0646 \u064a\u0643\u0648\u0646 \u0644\u0647\u0630\u0627 \u0627\u0644\u0634\u062e\u0635 \u062e\u0628\u0631\u0629 \u0641\u064a \u0645\u062c\u0627\u0644 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629.<\/p>\n<h3>3. \u062a\u0646\u0641\u064a\u0630 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0648\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631<\/h3>\n<p>\u062a\u062a\u0637\u0644\u0628 <a href=\"https:\/\/hsi-eg.co\/ar\/understanding-medical-device-regulations\/\" target=\"_blank\" rel=\"noopener\">\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 MDR<\/a> \u0645\u0646 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0623\u0646 \u064a\u0643\u0648\u0646 \u0644\u062f\u064a\u0647\u0627 \u0623\u0646\u0638\u0645\u0629 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0648\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u0644\u0647\u0630\u0627 \u0627\u0644\u0633\u0628\u0628 \u0627\u062e\u062a\u0627\u0631 \u0645\u0635\u0646\u0639\u0648 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0640 ISO 13485:2016 \u0644\u0623\u0646\u0647 \u064a\u064f\u0641\u062a\u0631\u0636 \u0623\u0646\u0647 \u064a\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 \u0645\u062a\u0637\u0644\u0628\u0627\u062a MDR \u0641\u064a\u0645\u0627 \u064a\u062a\u0639\u0644\u0642 \u0628\u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-2543\" src=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/MDR.webp\" alt=\"MDR\" width=\"1280\" height=\"711\" srcset=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/MDR.webp 1280w, https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/MDR-768x427.webp 768w\" sizes=\"auto, (max-width: 1280px) 100vw, 1280px\" \/><\/p>\n<h3>4. \u0625\u0639\u062f\u0627\u062f \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0641\u0646\u064a\u0629<\/h3>\n<p>\u062a\u062a\u0636\u0645\u0646 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0641\u0646\u064a\u0629\u060c \u0648\u0627\u0644\u0645\u0639\u0631\u0648\u0641\u0629 \u0623\u064a\u0636\u064b\u0627 \u0628\u0645\u0644\u0641\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0641\u0646\u064a\u0629\u060c \u0645\u0639\u0644\u0648\u0645\u0627\u062a \u062a\u0641\u0635\u064a\u0644\u064a\u0629 \u062d\u0648\u0644 \u062f\u0648\u0631\u0629 \u062d\u064a\u0627\u0629 \u062c\u0647\u0627\u0632\u0643 \u0627\u0644\u0637\u0628\u064a \u0648\u0647\u064a \u0645\u062a\u0637\u0644\u0628 \u0641\u064a MDR.<\/p>\n<h3>5. \u062a\u0646\u0641\u064a\u0630 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646<\/h3>\n<p>\u064a\u062a\u0637\u0644\u0628 MDR \u0645\u0646 \u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0623\u0646 \u064a\u0643\u0648\u0646 \u0644\u062f\u064a\u0647\u0627 \u0625\u062f\u0627\u0631\u0629 \u0644\u0644\u0645\u0648\u0631\u062f\u064a\u0646\u060c \u064a\u062c\u0628 \u062a\u062f\u0642\u064a\u0642 \u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646 \u0644\u0636\u0645\u0627\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0648\u0627\u0644\u062a\u0648\u0627\u0641\u0642\u060c \u0645\u0646 \u0627\u0644\u0645\u0641\u064a\u062f \u0625\u0646\u0634\u0627\u0621 \u0642\u0627\u0626\u0645\u0629 \u0628\u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u064a\u0646 \u0628\u0646\u0627\u0621\u064b \u0639\u0644\u0649 \u0645\u0639\u0627\u064a\u064a\u0631 \u0645\u062d\u062f\u062f\u0629 \u0645\u0633\u0628\u0642\u064b\u0627 \u0644\u0636\u0645\u0627\u0646 \u0623\u0646 \u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646 \u0627\u0644\u0645\u0624\u0647\u0644\u064a\u0646 \u0641\u0642\u0637 \u0647\u0645 \u0627\u0644\u0630\u064a\u0646 \u064a\u0642\u062f\u0645\u0648\u0646 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0648\u0627\u0644\u062e\u062f\u0645\u0627\u062a.<\/p>\n<h3>6. \u0625\u062c\u0631\u0627\u0621 \u062a\u0642\u064a\u064a\u0645 \u0633\u0631\u064a\u0631\u064a<\/h3>\n<p>\u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0623\u0646 \u062a\u0642\u0648\u0645 \u0628\u0625\u062c\u0631\u0627\u0621 \u062a\u0642\u064a\u064a\u0645 \u0633\u0631\u064a\u0631\u064a \u0644\u0625\u062b\u0628\u0627\u062a \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0623\u062f\u0627\u0621\u060c \u0645\u0646 \u0627\u0644\u0646\u0627\u062d\u064a\u0629 \u0627\u0644\u0639\u0645\u0644\u064a\u0629\u060c \u064a\u0639\u0646\u064a \u0630\u0644\u0643 \u0648\u0636\u0639 \u062e\u0637\u0629 \u0644\u062c\u0645\u0639 \u0648\u062a\u062d\u0644\u064a\u0644 \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0645\u0646 \u0627\u0644\u0623\u062f\u0628\u064a\u0627\u062a \u0627\u0644\u0639\u0644\u0645\u064a\u0629 \u0630\u0627\u062a \u0627\u0644\u0635\u0644\u0629 \u0648\u0627\u0644\u062a\u062d\u0642\u064a\u0642\u0627\u062a \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0627\u0644\u062a\u064a \u062a\u0634\u0645\u0644 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0637\u0628\u064a \u0627\u0644\u0645\u062d\u062f\u062f \u0623\u0648 \u0645\u0646\u062a\u062c\u064b\u0627 \u0645\u0639\u0627\u062f\u0644\u064b\u0627.<\/p>\n<h3>7. \u062a\u0639\u064a\u064a\u0646 \u0645\u0645\u062b\u0644 \u0645\u0639\u062a\u0645\u062f \u0641\u064a \u0623\u0648\u0631\u0648\u0628\u0627 (\u0625\u0630\u0627 \u0644\u0632\u0645 \u0627\u0644\u0623\u0645\u0631)<\/h3>\n<p>\u0625\u0630\u0627 \u0643\u0627\u0646\u062a \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0644\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0637\u0628\u064a \u0644\u064a\u0633\u062a \u0645\u0642\u0631\u0647\u0627 \u0641\u064a \u0627\u0644\u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0627\u0642\u062a\u0635\u0627\u062f\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 (EEA)\u060c \u0641\u0633\u0648\u0641 \u062a\u062d\u062a\u0627\u062c \u0625\u0644\u0649 \u062a\u0639\u064a\u064a\u0646 \u0645\u0645\u062b\u0644 \u0645\u0639\u062a\u0645\u062f \u062f\u0627\u062e\u0644 \u062f\u0648\u0644 \u0627\u0644\u0623\u0639\u0636\u0627\u0621.<\/p>\n<p>\u0627\u0644\u0645\u0645\u062b\u0644 \u0627\u0644\u0645\u0639\u062a\u0645\u062f \u0645\u0633\u0624\u0648\u0644 \u0639\u0646 \u0627\u062a\u062e\u0627\u0630 \u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0645\u062b\u0644:<\/p>\n<ul>\n<li>\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0641\u0646\u064a\u0629<\/li>\n<li>\u0625\u0628\u0644\u0627\u063a \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0628\u0627\u0644\u0634\u0643\u0627\u0648\u0649<\/li>\n<li>\u062a\u0633\u062c\u064a\u0644 \u0645\u0643\u0627\u0646 \u0641\u0639\u0644\u064a \u0644\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u0628\u0644\u063a\u0629 \u0644\u0627\u0633\u062a\u0642\u0628\u0627\u0644 \u0639\u064a\u0646\u0627\u062a \u0645\u0646 \u0627\u0644\u062c\u0647\u0627\u0632 \u0644\u0644\u062a\u0641\u062a\u064a\u0634<\/li>\n<\/ul>\n<h3>8. \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 \u0645\u0646 \u0647\u064a\u0626\u0629 \u0645\u0628\u0644\u063a\u0629<\/h3>\n<p>\u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u0628\u0644\u063a\u0629 \u0647\u064a \u0645\u0646\u0638\u0645\u0629 \u0645\u0633\u062a\u0642\u0644\u0629 \u062a\u0647\u062f\u0641 \u0625\u0644\u0649 \u062a\u0642\u064a\u064a\u0645 \u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0645\u062d\u062f\u062f\u0629 \u0642\u0628\u0644 \u0637\u0631\u062d\u0647\u0627 \u0641\u064a \u0627\u0644\u0633\u0648\u0642\u060c \u0641\u064a\u0645\u0627 \u064a\u062a\u0639\u0644\u0642 \u0628\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u0641\u0647\u064a \u0645\u0633\u0624\u0648\u0644\u0629 \u0639\u0646 \u062a\u062f\u0642\u064a\u0642 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0648\u0625\u0635\u062f\u0627\u0631 \u0627\u0644\u0634\u0647\u0627\u062f\u0627\u062a \u0628\u0634\u0623\u0646 \u062a\u0648\u0627\u0641\u0642 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0645\u0639 MDR.<\/p>\n<p>\u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0645\u0646 \u0627\u0644\u0641\u0626\u0627\u062a \u0627\u0644\u0623\u0639\u0644\u0649\u060c \u0641\u0625\u0646 \u0647\u0630\u0647 \u0627\u0644\u0634\u0647\u0627\u062f\u0629 \u0625\u0644\u0632\u0627\u0645\u064a\u0629\u060c \u0648\u0645\u062d\u062f\u062f\u0629 \u0644\u0643\u0644 \u0625\u062c\u0631\u0627\u0621\u060c \u0648\u0644\u0647\u0627 \u0635\u0644\u0627\u062d\u064a\u0629 \u0623\u0642\u0635\u0627\u0647\u0627 \u062e\u0645\u0633 \u0633\u0646\u0648\u0627\u062a\u060c \u0628\u0639\u062f \u0630\u0644\u0643\u060c \u0633\u062a\u0642\u0648\u0645 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u0628\u0644\u063a\u0629 \u0628\u062a\u062f\u0642\u064a\u0642 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 (QMS) \u0648\u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0641\u0646\u064a\u0629 \u0644\u0644\u0645\u0635\u0646\u0639 \u0644\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0645\u0639 MDR \u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-2525\" src=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/\u0641\u0647\u0645-\u0639\u0644\u0627\u0645\u0629-CE-\u0644\u0644\u0623\u062c\u0647\u0632\u0629-\u0627\u0644\u0637\u0628\u064a\u0629.jpg\" alt=\"\u0641\u0647\u0645 \u0639\u0644\u0627\u0645\u0629 CE \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\" width=\"1200\" height=\"674\" srcset=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/\u0641\u0647\u0645-\u0639\u0644\u0627\u0645\u0629-CE-\u0644\u0644\u0623\u062c\u0647\u0632\u0629-\u0627\u0644\u0637\u0628\u064a\u0629.jpg 1200w, https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/\u0641\u0647\u0645-\u0639\u0644\u0627\u0645\u0629-CE-\u0644\u0644\u0623\u062c\u0647\u0632\u0629-\u0627\u0644\u0637\u0628\u064a\u0629-768x431.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/p>\n<h3>9. \u0625\u0639\u062f\u0627\u062f \u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u062a\u0648\u0627\u0641\u0642<\/h3>\n<p>\u0628\u0639\u062f \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0627\u0644\u0634\u0647\u0627\u062f\u0629 \u0645\u0646 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u0628\u0644\u063a\u0629\u060c \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0625\u0639\u062f\u0627\u062f \u0625\u0639\u0644\u0627\u0646 \u0627\u0644\u062a\u0648\u0627\u0641\u0642\u060c \u0645\u0639 \u062a\u062d\u0645\u0644 \u0627\u0644\u0645\u0633\u0624\u0648\u0644\u064a\u0629 \u0628\u0623\u0646 \u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0645\u062d\u062f\u062f\u0629 \u0641\u064a MDR \u0642\u062f \u062a\u0645 \u0627\u0644\u0648\u0641\u0627\u0621 \u0628\u0647\u0627.<\/p>\n<h3>10. \u062a\u0633\u062c\u064a\u0644 \u062c\u0647\u0627\u0632\u0643 \u062a\u062d\u062a \u0645\u0639\u0631\u0641 \u062c\u0647\u0627\u0632 \u0641\u0631\u064a\u062f<\/h3>\n<p>\u0644\u062a\u0633\u0647\u064a\u0644 \u062a\u062a\u0628\u0639 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u064a\u062c\u0628 \u062a\u062e\u0635\u064a\u0635 \u0645\u0639\u0631\u0641 \u062c\u0647\u0627\u0632 \u0641\u0631\u064a\u062f (UDI) \u0644\u0643\u0644 \u0646\u0645\u0648\u0630\u062c \u062c\u0647\u0627\u0632 \u0639\u0644\u0649 \u062d\u062f\u0629.<\/p>\n<p>\u0627\u0644\u0640 UDI \u0647\u0648 \u0631\u0642\u0645 \u0641\u0631\u064a\u062f \u0623\u0648 \u0631\u0645\u0632 \u0623\u0628\u062c\u062f\u064a \u0631\u0642\u0645\u064a \u064a\u062a\u0645 \u062a\u062e\u0632\u064a\u0646\u0647 \u0641\u064a \u0642\u0627\u0639\u062f\u0629 \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 (EUDAMED)\u060c \u062d\u064a\u062b \u064a\u0645\u0643\u0646 \u0627\u0644\u0639\u062b\u0648\u0631 \u0639\u0644\u0649 \u0627\u0644\u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629 \u062d\u0648\u0644 \u0627\u0644\u062c\u0647\u0627\u0632\u060c \u0625\u0636\u0627\u0641\u0629 \u0627\u0644\u0640 UDI \u0647\u064a \u0645\u062a\u0637\u0644\u0628 \u0625\u0636\u0627\u0641\u064a \u0648\u0644\u0627 \u062a\u062d\u0644 \u0645\u062d\u0644 \u0639\u0644\u0627\u0645\u0629 CE \u0623\u0648 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0648\u0633\u0645 \u0627\u0644\u0623\u062e\u0631\u0649.<\/p>\n<h3>11. \u0648\u0636\u0639 \u0639\u0644\u0627\u0645\u0629 CE \u0639\u0644\u0649 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0637\u0628\u064a<\/h3>\n<p>\u0628\u0639\u062f \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0645\u0646 \u0627\u0644\u0633\u0644\u0637\u0627\u062a \u0627\u0644\u0648\u0637\u0646\u064a\u0629 \u0648\u0627\u0644\u0634\u0647\u0627\u062f\u0629 \u0645\u0646 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u0628\u0644\u063a\u0629\u060c \u064a\u0645\u0643\u0646 \u0644\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0648\u0636\u0639 \u0639\u0644\u0627\u0645\u0629 CE \u0639\u0644\u0649 \u0623\u062c\u0647\u0632\u062a\u0647\u0627 \u0627\u0644\u0637\u0628\u064a\u0629.<\/p>\n<p>\u064a\u062c\u0628 \u0648\u0636\u0639 \u0639\u0644\u0627\u0645\u0629 CE \u0639\u0644\u0649 \u0627\u0644\u062c\u0647\u0627\u0632 \u0646\u0641\u0633\u0647\u060c \u0648\u0639\u0644\u0649 \u0627\u0644\u0639\u0628\u0648\u0629\u060c \u0648\u0639\u0644\u0649 \u0623\u064a \u062a\u0639\u0644\u064a\u0645\u0627\u062a \u0644\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645\u060c \u0645\u0646 \u0627\u0644\u0645\u0647\u0645 \u0623\u0646 \u062a\u0643\u0648\u0646 \u0639\u0644\u0627\u0645\u0629 CE \u0645\u0631\u0626\u064a\u0629 \u0648\u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u0642\u0631\u0627\u0621\u0629 \u0648\u0645\u0635\u0646\u0648\u0639\u0629 \u0645\u0646 \u0645\u0627\u062f\u0629 \u0644\u0627 \u064a\u0645\u0643\u0646 \u063a\u0633\u0644\u0647\u0627.<\/p>\n<p>\u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 II \u0648 III\u060c \u064a\u062c\u0628 \u0623\u064a\u0636\u064b\u0627 \u0637\u0628\u0627\u0639\u0629 \u0627\u0644\u0631\u0642\u0645 \u0627\u0644\u0645\u0643\u0648\u0646 \u0645\u0646 \u0623\u0631\u0628\u0639\u0629 \u0623\u0631\u0642\u0627\u0645 \u0627\u0644\u062e\u0627\u0635 \u0628\u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u0628\u0644\u063a\u0629 \u0628\u062c\u0627\u0646\u0628 \u0639\u0644\u0627\u0645\u0629 CE.<\/p>\n<h3>12. \u0627\u0644\u062d\u0641\u0627\u0638 \u0639\u0644\u0649 \u0627\u0644\u0645\u0631\u0627\u0642\u0628\u0629 \u0628\u0639\u062f \u0627\u0644\u0633\u0648\u0642<\/h3>\n<p>\u0642\u0628\u0644 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0639\u0644\u0627\u0645\u0629 CE \u0648\u0648\u0636\u0639 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0637\u0628\u064a \u0641\u064a \u0633\u0648\u0642 \u0627\u0644\u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0627\u0642\u062a\u0635\u0627\u062f\u064a\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 (EEA)\u060c \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0623\u0646 \u062a\u0638\u0647\u0631 \u0623\u0646 \u0646\u0638\u0627\u0645 \u0627\u0644\u0645\u0631\u0627\u0642\u0628\u0629 \u0628\u0639\u062f \u0627\u0644\u0633\u0648\u0642 \u0642\u062f \u062a\u0645 \u062a\u0646\u0641\u064a\u0630\u0647 \u0628\u0627\u0644\u0641\u0639\u0644 \u0644\u0645\u0639\u0627\u0644\u062c\u0629 \u0627\u0644\u0623\u0633\u0626\u0644\u0629 \u0627\u0644\u0645\u062a\u0639\u0644\u0642\u0629 \u0628\u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0641\u0639\u0627\u0644\u064a\u0629.<\/p>\n<p>\u064a\u062c\u0628 \u0639\u0644\u0649 \u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u062c\u0645\u0639 \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0645\u062a\u0639\u0644\u0642\u0629 \u0628\u0623\u062c\u0647\u0632\u062a\u0647\u0627 \u0627\u0644\u0645\u0628\u0627\u0639\u0629 \u0645\u0646 \u062e\u0644\u0627\u0644 \u0627\u0644\u0645\u0631\u0627\u0642\u0628\u0629 \u0628\u0639\u062f \u0627\u0644\u0633\u0648\u0642\u060c \u0648\u0627\u0644\u0645\u0631\u0627\u0642\u0628\u0629 \u0627\u0644\u064a\u0642\u0638\u0629\u060c \u0648\u062e\u0637\u0637 \u0627\u0644\u0645\u0631\u0627\u0642\u0628\u0629 \u0627\u0644\u0633\u0648\u0642\u064a\u0629.<\/p>\n<p>\u064a\u062a\u0636\u0645\u0646 \u0647\u0630\u0627 \u0627\u0644\u062a\u0639\u0644\u064a\u0642\u0627\u062a \u0627\u0644\u0645\u062a\u0639\u0644\u0642\u0629 \u0628\u062a\u0642\u064a\u064a\u0645 \u062a\u062c\u0631\u0628\u0629 \u0627\u0644\u0645\u0631\u0636\u0649 \u0645\u0639 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0637\u0628\u064a \u0648\u062f\u0648\u0631\u0629 \u062d\u064a\u0627\u0629 \u0627\u0644\u0645\u0646\u062a\u062c.<\/p>\n<p><strong>\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u062a\u0634\u0645\u0644:<\/strong><\/p>\n<ul>\n<li>\u0645\u062a\u0627\u0628\u0639\u0629 \u0627\u0644\u0634\u0643\u0627\u0648\u0649 \u0648\u0627\u0644\u062d\u0648\u0627\u062f\u062b \u0627\u0644\u0633\u0644\u0628\u064a\u0629 \u0648\u062d\u0627\u0644\u0627\u062a \u0639\u062f\u0645 \u0627\u0644\u0645\u0637\u0627\u0628\u0642\u0629<\/li>\n<li>\u062a\u062d\u062f\u064a\u062b \u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0628\u0634\u0643\u0644 \u062f\u0648\u0631\u064a<\/li>\n<li>\u0625\u062c\u0631\u0627\u0621 \u062a\u062f\u0642\u064a\u0642 \u062f\u0627\u062e\u0644\u064a \u0648\u062a\u062f\u0642\u064a\u0642 \u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646 \u0628\u0634\u0643\u0644 \u0645\u0646\u062a\u0638\u0645<\/li>\n<li>\u0627\u0644\u062d\u0641\u0627\u0638 \u0639\u0644\u0649 \u062a\u062d\u062f\u064a\u062b \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0641\u0646\u064a\u0629\u060c \u0648\u0642\u0648\u0627\u0639\u062f \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a\u060c \u0648\u0627\u0644\u0633\u062c\u0644\u0627\u062a<\/li>\n<\/ul>\n<p>\u062a\u0636\u0645\u0646 \u0647\u0630\u0647 \u0627\u0644\u0645\u0631\u0627\u0642\u0628\u0629 \u0627\u062a\u062e\u0627\u0630 \u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0633\u062a\u0628\u0627\u0642\u064a\u0629 \u0644\u062c\u0645\u0639 \u0648\u0645\u0631\u0627\u062c\u0639\u0629 \u0645\u0639\u0644\u0648\u0645\u0627\u062a \u062c\u0648\u062f\u0629 \u0627\u0644\u062c\u0647\u0627\u0632 \u0648\u0633\u0644\u0627\u0645\u062a\u0647 \u0628\u0646\u0627\u0621\u064b \u0639\u0644\u0649 \u0627\u0644\u0623\u062f\u0644\u0629 \u0627\u0644\u0648\u0627\u0642\u0639\u064a\u0629. \u0648\u0628\u0627\u0644\u062a\u0627\u0644\u064a\u060c \u064a\u0645\u0643\u0646 \u0644\u0644\u0645\u0635\u0646\u0639\u064a\u0646 \u0645\u0639\u0627\u0644\u062c\u0629 \u0634\u0643\u0627\u0648\u0649 \u0627\u0644\u0639\u0645\u0644\u0627\u0621 \u0628\u0634\u0643\u0644 \u0623\u0641\u0636\u0644\u060c \u0648\u062a\u062d\u062f\u064a\u062f \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u0648\u062a\u0646\u0641\u064a\u0630 \u0627\u0633\u062a\u0631\u062c\u0627\u0639 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0648\u063a\u064a\u0631\u0647\u0627 \u0645\u0646 \u0627\u0644\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u0633\u0648\u0642\u064a\u0629.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-2554\" src=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/Medical-Devices.jpg\" alt=\"Medical Devices\" width=\"1600\" height=\"900\" srcset=\"https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/Medical-Devices.jpg 1600w, https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/Medical-Devices-1280x720.jpg 1280w, https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/Medical-Devices-768x432.jpg 768w, https:\/\/hsi-eg.co\/wp-content\/uploads\/2025\/04\/Medical-Devices-1536x864.jpg 1536w\" sizes=\"auto, (max-width: 1600px) 100vw, 1600px\" \/><\/p>\n<h2>\u0627\u0644\u0623\u0633\u0626\u0644\u0629 \u0627\u0644\u0634\u0627\u0626\u0639\u0629 \u062d\u0648\u0644 \u0639\u0644\u0627\u0645\u0629 CE<\/h2>\n<p>\u0628\u0639\u0636 \u0627\u0644\u0623\u0633\u0626\u0644\u0629 \u0627\u0644\u0634\u0627\u0626\u0639\u0629 \u062d\u0648\u0644 \u0639\u0644\u0627\u0645\u0629 CE \u0641\u064a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0648\u0627\u0644\u062a\u064a \u062a\u0636\u0645\u0646 \u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0635\u062d\u0629 \u0648\u062d\u0645\u0627\u064a\u0629 \u0627\u0644\u0628\u064a\u0626\u0629<\/p>\n<h3>1- \u0647\u0644 \u0639\u0644\u0627\u0645\u0629 CE \u0647\u064a \u0646\u0641\u0633\u0647\u0627 \u0645\u0648\u0627\u0641\u0642\u0629 FDA\u061f<\/h3>\n<p>\u062a\u0647\u062f\u0641 \u0643\u0644 \u0645\u0646 \u0639\u0644\u0627\u0645\u0629 CE \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0648\u0645\u0648\u0627\u0641\u0642\u0629 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 (FDA) \u0625\u0644\u0649 \u062a\u0642\u064a\u064a\u0645 \u0633\u0644\u0627\u0645\u0629 \u0648\u0641\u0639\u0627\u0644\u064a\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629. \u0648\u0645\u0639 \u0630\u0644\u0643\u060c \u0641\u0625\u0646\u0647\u0645\u0627 \u0635\u0627\u0644\u062d\u0627\u0646 \u0641\u0642\u0637 \u0641\u064a \u0627\u0644\u0623\u0633\u0648\u0627\u0642 \u0627\u0644\u062a\u064a \u062a\u0645 \u062a\u062d\u062f\u064a\u062f\u0647\u0645\u0627 \u0644\u0647\u0627.<\/p>\n<h3>2- \u0645\u0627 \u0647\u064a \u0645\u062f\u0629 \u0635\u0644\u0627\u062d\u064a\u0629 \u0639\u0644\u0627\u0645\u0629 CE\u061f<\/h3>\n<p>\u064a\u062a\u0645 \u062a\u062d\u062f\u064a\u062f \u0635\u0644\u0627\u062d\u064a\u0629 \u0639\u0644\u0627\u0645\u0629 CE \u0645\u0646 \u0642\u0628\u0644 \u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u0645\u0628\u0644\u063a\u0629 \u0648\u062a\u0639\u062a\u0645\u062f \u0639\u0644\u0649 \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0637\u0628\u064a\u060c \u0648\u0644\u0643\u0646 \u0644\u0627 \u064a\u0645\u0643\u0646 \u0623\u0646 \u062a\u062a\u062c\u0627\u0648\u0632 \u062e\u0645\u0633 \u0633\u0646\u0648\u0627\u062a. \u0628\u0639\u062f \u0630\u0644\u0643\u060c \u064a\u062c\u0628 \u0625\u0639\u0627\u062f\u0629 \u062a\u0635\u062f\u064a\u0642 \u0627\u0644\u062c\u0647\u0627\u0632.<\/p>\n<p>\u0639\u0644\u0649 \u0633\u0628\u064a\u0644 \u0627\u0644\u0645\u062b\u0627\u0644\u060c \u064a\u0645\u0643\u0646 \u0644\u0644\u062c\u0647\u0627\u0632 \u0645\u0646 \u0627\u0644\u0641\u0626\u0629 IIa \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 \u0635\u0627\u0644\u062d\u0629 \u0644\u0645\u062f\u0629 \u062b\u0644\u0627\u062b \u0633\u0646\u0648\u0627\u062a \u0641\u0642\u0637\u060c \u0639\u0644\u0627\u0648\u0629 \u0639\u0644\u0649 \u0630\u0644\u0643\u060c \u064a\u062a\u0645 \u0625\u062c\u0631\u0627\u0621 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\u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646 \u0644\u062f\u0649 \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u062c\u0648\u062f\u0629 (QMS) \u0628\u0627\u0644\u0641\u0639\u0644 \u0648\u0645\u0639\u062a\u0645\u062f\u0629 \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0639\u064a\u0627\u0631 ISO 13485:2016. \u0639\u0627\u062f\u0629\u064b \u0645\u0627 \u064a\u0633\u062a\u063a\u0631\u0642 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0639\u0644\u0627\u0645\u0629 CE \u0645\u0646 16 \u0625\u0644\u0649 18 \u0634\u0647\u0631\u064b\u0627 \u0645\u0646 \u0627\u0644\u0628\u062f\u0627\u064a\u0629 \u0625\u0644\u0649 \u0627\u0644\u0646\u0647\u0627\u064a\u0629.<\/p>\n<h3>5- \u0643\u0645 \u0639\u062f\u062f \u0627\u0644\u0647\u064a\u0626\u0627\u062a \u0627\u0644\u0645\u0628\u0644\u063a\u0629 \u0627\u0644\u062e\u0627\u0635\u0629 \u0628\u0639\u0644\u0627\u0645\u0629 CE\u061f<\/h3>\n<p>\u0648\u0641\u0642\u064b\u0627 \u0644\u0642\u0627\u0639\u062f\u0629 \u0628\u064a\u0627\u0646\u0627\u062a NANDO\u060c \u0641\u064a \u0639\u0627\u0645 2022\u060c \u0643\u0627\u0646\u062a \u0647\u0646\u0627\u0643 34 \u0647\u064a\u0626\u0629 \u0645\u0628\u0644\u063a\u0629 \u0645\u0639\u062a\u0645\u062f\u0629 \u0644\u0640 MDR \u06487 \u0644\u0640 IVDR.<\/p>\n<p><strong>\u0627\u0644\u0645\u0635\u062f\u0631:<\/strong> <a href=\"https:\/\/simplerqms.com\/ce-marking-for-medical-devices\/\" target=\"_blank\" rel=\"noopener\">CE Marking for Medical Devices [Step-by-Step Guide]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u064a\u062a\u0637\u0644\u0628 \u0628\u064a\u0639 \u0648\u062a\u0633\u0648\u064a\u0642 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0641\u064a \u062f\u0648\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a (EU) \u0623\u0646 \u062a\u062d\u0645\u0644 \u0639\u0644\u0627\u0645\u0629 CE \u0643\u0645\u0627 \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0644\u0636\u0645\u0627\u0646 \u0623\u0646 \u0645\u0646\u062a\u062c\u0627\u062a\u0647\u0627 \u062a\u0644\u062a\u0632\u0645 \u0628\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u062c\u0648\u062f\u0629 \u0648\u0627\u0644\u0633\u0644\u0627\u0645\u0629\u060c \u064a\u0645\u0643\u0646 \u0623\u0646 \u062a\u0643\u0648\u0646 \u0627\u0644\u062a\u0634\u0631\u064a\u0639\u0627\u062a \u0648\u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u062f\u0648\u0644\u064a\u0629 \u0627\u0644\u0645\u062a\u0639\u0644\u0642\u0629 \u0628\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u0645\u062b\u0644 \u0627\u0644\u0644\u0627\u0626\u062d\u0629 \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 MDR 2017\/745 \u0648ISO 13485:2016\u060c \u0645\u0639\u0642\u062f\u0629 \u0648\u0644\u0643\u0646\u0647\u0627 \u0623\u0633\u0627\u0633\u064a\u0629 \u0648\u0639\u062f\u0645 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0647\u0630\u0647 \u0627\u0644\u0644\u0648\u0627\u0626\u062d \u0648\u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2521,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1084,1684],"tags":[1459,1481,1477,183,1479,1476,1478,1483,1473,1480,1472,1482,1475,1474],"class_list":{"0":"post-2491","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","6":"hentry","7":"category-medical-devices","8":"category-accreditations","9":"tag-ce-marking","10":"tag-ce--","11":"tag-mdr","12":"tag-183","13":"tag-1479","14":"tag-1476","15":"tag-1478","16":"tag---ce","17":"tag--ce","18":"tag-1480","20":"tag----ce"},"acf":[],"_links":{"self":[{"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/posts\/2491","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/comments?post=2491"}],"version-history":[{"count":18,"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/posts\/2491\/revisions"}],"predecessor-version":[{"id":2556,"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/posts\/2491\/revisions\/2556"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/media\/2521"}],"wp:attachment":[{"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/media?parent=2491"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/categories?post=2491"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hsi-eg.co\/ar\/wp-json\/wp\/v2\/tags?post=2491"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}