{"id":19,"date":"2012-10-19T14:33:43","date_gmt":"2012-10-19T14:33:43","guid":{"rendered":"http:\/\/www.qualityinquality.gr\/?page_id=19"},"modified":"2026-04-09T10:12:42","modified_gmt":"2026-04-09T07:12:42","slug":"iso-134852003","status":"publish","type":"page","link":"https:\/\/www.qualityinquality.gr\/?page_id=19","title":{"rendered":"ISO 13485\/2016 (medical devices)"},"content":{"rendered":"<p style=\"text-align: justify;\"><a href=\"http:\/\/www.qualityinquality.gr\/wp-content\/uploads\/2012\/10\/iso-13485.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\" wp-image-227 aligncenter\" src=\"http:\/\/www.qualityinquality.gr\/wp-content\/uploads\/2012\/10\/iso-13485.jpg\" alt=\"iso 13485\" width=\"242\" height=\"172\" \/><\/a><\/p>\n<h3 style=\"text-align: justify;\"><strong>\u0393\u03b9\u03b1\u03c4\u03af \u03c3\u03b5 \u03b5\u03bc\u03ac\u03c2;<\/strong><\/h3>\n<p style=\"text-align: justify;\">\u0388\u03c7\u03bf\u03bd\u03c4\u03b1\u03c2 \u03c3\u03c7\u03b5\u03b4\u03cc\u03bd 25 \u03c7\u03c1\u03cc\u03bd\u03b9\u03b1 \u03b5\u03bc\u03c0\u03b5\u03b9\u03c1\u03af\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b5\u03c7\u03bd\u03bf\u03b3\u03bd\u03c9\u03c3\u03af\u03b1 \u03c3\u03c4\u03bf\u03bd \u03c3\u03c5\u03b3\u03ba\u03b5\u03ba\u03c1\u03b9\u03bc\u03ad\u03bd\u03bf \u03c7\u03ce\u03c1\u03bf \u03c4\u03c9\u03bd \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd \u03ba\u03b1\u03b9 \u03ad\u03c7\u03bf\u03bd\u03c4\u03b1\u03c2 \u03bc\u03ad\u03c7\u03c1\u03b9 \u03c3\u03ae\u03bc\u03b5\u03c1\u03b1 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03b9\u03ae\u03c3\u03b5\u03b9 \u03c0\u03ac\u03bd\u03c9 \u03b1\u03c0\u03cc 80 \u03a3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03b1 \u03a0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03c9\u03c2 \u03c0\u03c1\u03bf\u03c2 \u03c4\u03bf <a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a> \u03c3\u03b5 \u03cc\u03bb\u03b5\u03c2 \u03c4\u03b9\u03c2 \u03bc\u03bf\u03c1\u03c6\u03ad\u03c2 \u03b4\u03c1\u03b1\u03c3\u03c4\u03b7\u03c1\u03b9\u03bf\u03c4\u03ae\u03c4\u03c9\u03bd (\u03c0\u03b1\u03c1\u03b1\u03b3\u03c9\u03b3\u03ae, \u03b5\u03bc\u03c0\u03bf\u03c1\u03af\u03b1, \u03c4\u03b5\u03c7\u03bd\u03b9\u03ba\u03ae \u03c5\u03c0\u03bf\u03c3\u03c4\u03ae\u03c1\u03b9\u03be\u03b7), \u03bc\u03b1\u03c2 \u03ba\u03ac\u03bd\u03b5\u03b9 \u03c4\u03bf\u03c5\u03c2 \u03b9\u03b4\u03b1\u03bd\u03b9\u03ba\u03cc\u03c4\u03b5\u03c1\u03bf\u03c5\u03c2 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03ac\u03c4\u03b5\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03b5\u03b3\u03ba\u03b1\u03c4\u03ac\u03c3\u03c4\u03b1\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03b1\u03c5\u03c4\u03ce\u03bd \u03c4\u03c9\u03bd \u03a3\u03c5\u03c3\u03c4\u03b7\u03bc\u03ac\u03c4\u03c9\u03bd.<\/p>\n<p style=\"text-align: justify;\">\u0397 \u03b5\u03bc\u03c0\u03b5\u03b9\u03c1\u03af\u03b1 \u03bc\u03b1\u03c2, \u03b7 \u03c4\u03b5\u03c7\u03bd\u03bf\u03b3\u03bd\u03c9\u03c3\u03af\u03b1 \u03bc\u03b1\u03c2 \u03ba\u03b1\u03b9 \u03b7 \u03b4\u03b9\u03ac\u03c1\u03ba\u03b5\u03b9\u03ac \u03bc\u03b1\u03c2 \u03c3\u03c4\u03bf\u03bd \u03c7\u03ce\u03c1\u03bf \u03c4\u03c9\u03bd \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd \u03b5\u03af\u03bd\u03b1\u03b9 \u03b7 \u03ba\u03b1\u03bb\u03bb\u03af\u03c4\u03b5\u03c1\u03b7 \u03b5\u03be\u03b1\u03c3\u03c6\u03ac\u03bb\u03b9\u03c3\u03b7 \u03b3\u03b9\u03b1 \u03b5\u03c3\u03ac\u03c2 \u03ba\u03b1\u03b9 \u03c4\u03bf \u03bc\u03ad\u03bb\u03bb\u03bf\u03bd \u03c4\u03b7\u03c2 \u03b5\u03c0\u03b9\u03c7\u03b5\u03af\u03c1\u03b7\u03c3\u03ae\u03c2 \u03c3\u03b1\u03c2.<\/p>\n<h3><strong>\u03a4\u03b9 \u03b5\u03af\u03bd\u03b1\u03b9 \u03c4\u03bf<\/strong> <strong>ISO<\/strong><strong> 13485?<\/strong><\/h3>\n<p style=\"text-align: justify;\">\u03a4\u03bf \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf <a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a> \u03bf\u03c1\u03af\u03b6\u03b5\u03b9 \u03c4\u03b9\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03b3\u03b9\u03b1 \u03ad\u03bd\u03b1 \u03a3\u03cd\u03c3\u03c4\u03b7\u03bc\u03b1 \u0394\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u03a0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03b3\u03b9\u03b1 \u03b5\u03c4\u03b1\u03b9\u03c1\u03b5\u03af\u03b5\u03c2 \u03c0\u03bf\u03c5 \u03b4\u03c1\u03b1\u03c3\u03c4\u03b7\u03c1\u03b9\u03bf\u03c0\u03bf\u03b9\u03bf\u03cd\u03bd\u03c4\u03b1\u03b9 \u03bc\u03b5 \u03c4\u03bf\u03bd \u03c3\u03c7\u03b5\u03b4\u03b9\u03b1\u03c3\u03bc\u03cc, \u03c4\u03b7\u03bd \u03c0\u03b1\u03c1\u03b1\u03b3\u03c9\u03b3\u03ae, \u03c4\u03b7\u03bd \u03b5\u03bc\u03c0\u03bf\u03c1\u03af\u03b1, \u03c4\u03b7\u03bd \u03b5\u03b3\u03ba\u03b1\u03c4\u03ac\u03c3\u03c4\u03b1\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03c4\u03b5\u03c7\u03bd\u03b9\u03ba\u03ae \u03c5\u03c0\u03bf\u03c3\u03c4\u03ae\u03c1\u03b9\u03be\u03b7 \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd. \u03a4\u03bf \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf <a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a> \u03b5\u03af\u03bd\u03b1\u03b9 \u03b2\u03b1\u03c3\u03b9\u03c3\u03bc\u03ad\u03bd\u03bf \u03c3\u03c4\u03b9\u03c2 \u03b1\u03c1\u03c7\u03ad\u03c2 \u03c4\u03bf\u03c5 ISO 9001 \u03ba\u03b1\u03b9 \u03b1\u03ba\u03bf\u03bb\u03bf\u03c5\u03b8\u03b5\u03af \u03c4\u03b7 \u03b4\u03b9\u03b5\u03c1\u03b3\u03b1\u03c3\u03b9\u03b1\u03ba\u03ae \u03c0\u03c1\u03bf\u03c3\u03ad\u03b3\u03b3\u03b9\u03c3\u03b7 \u03c4\u03b7\u03c2 \u0394\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u03a0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2.<\/p>\n<h3><strong>\u03a3\u03b5 \u03c0\u03bf\u03b9\u03bf\u03c5\u03c2 \u03b1\u03c0\u03b5\u03c5\u03b8\u03cd\u03bd\u03b5\u03c4\u03b1\u03b9;<\/strong><\/h3>\n<p>\u038c\u03bb\u03bf\u03b9 \u03bf\u03b9 \u039f\u03c1\u03b3\u03b1\u03bd\u03b9\u03c3\u03bc\u03bf\u03af \u03ba\u03b1\u03b9 \u03bf\u03b9 \u03c0\u03b1\u03c1\u03b1\u03b3\u03c9\u03b3\u03b9\u03ba\u03ad\u03c2 \u0395\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c0\u03bf\u03c5 \u03b4\u03c1\u03b1\u03c3\u03c4\u03b7\u03c1\u03b9\u03bf\u03c0\u03bf\u03b9\u03bf\u03cd\u03bd\u03c4\u03b1\u03b9 \u03c3\u03c4\u03bf \u03ba\u03bb\u03ac\u03b4\u03bf \u03c4\u03c9\u03bd \u0399\u03b1\u03c4\u03c1\u03b9\u03ba\u03ce\u03bd \u03a0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd \u03bc\u03c0\u03bf\u03c1\u03bf\u03cd\u03bd, \u03b5\u03ac\u03bd \u03ba\u03b1\u03b9 \u03b5\u03c6\u03cc\u03c3\u03bf\u03bd \u03c4\u03bf \u03b5\u03c0\u03b9\u03b8\u03c5\u03bc\u03bf\u03cd\u03bd, \u03bd\u03b1 \u03b5\u03c6\u03b1\u03c1\u03bc\u03cc\u03c3\u03bf\u03c5\u03bd \u03ba\u03b1\u03b9 \u03bd\u03b1 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03b9\u03ae\u03c3\u03bf\u03c5\u03bd \u03ad\u03bd\u03b1 \u03a3\u03cd\u03c3\u03c4\u03b7\u03bc\u03b1 \u0394\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u03a0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2\u00a0\u03ba\u03b1\u03c4\u03ac ISO 13485, \u03c0\u03c1\u03bf\u03c3\u03b1\u03c1\u03bc\u03bf\u03c3\u03bc\u03ad\u03bd\u03bf \u03c3\u03c4\u03bf \u03bc\u03ad\u03b3\u03b5\u03b8\u03bf\u03c2, \u03c4\u03bf \u03b5\u03af\u03b4\u03bf\u03c2 \u03ba\u03b1\u03b8\u03ce\u03c2 \u03ba\u03b1\u03b9 \u03c4\u03b9\u03c2 \u03b4\u03c1\u03b1\u03c3\u03c4\u03b7\u03c1\u03b9\u03cc\u03c4\u03b7\u03c4\u03ad\u03c2 \u03c4\u03bf\u03c5\u03c2.<\/p>\n<h3><strong>\u039a\u03cd\u03c1\u03b9\u03b1 \u03a7\u03b1\u03c1\u03b1\u03ba\u03c4\u03b7\u03c1\u03b9\u03c3\u03c4\u03b9\u03ba\u03ac \u03c4\u03bf\u03c5 ISO 13485\/2016<\/strong><\/h3>\n<p>\u03a4\u03b1 \u03ba\u03cd\u03c1\u03b9\u03b1 \u03c7\u03b1\u03c1\u03b1\u03ba\u03c4\u03b7\u03c1\u03b9\u03c3\u03c4\u03b9\u03ba\u03ac \u03c4\u03bf\u03c5 \u03b5\u03c0\u03b9\u03ba\u03b5\u03bd\u03c4\u03c1\u03ce\u03bd\u03bf\u03bd\u03c4\u03b1\u03b9 \u03c3\u03c4\u03b7\u03bd \u03b1\u03c3\u03c6\u03ac\u03bb\u03b5\u03b9\u03b1 \u03c4\u03c9\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd \u03ba\u03b1\u03b9 \u03c3\u03c4\u03b7 \u03c3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03bc\u03b5 \u03c4\u03b9\u03c2 \u03ba\u03b1\u03bd\u03bf\u03bd\u03b9\u03c3\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2.<\/p>\n<ol>\n<li><strong>\u0394\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u039a\u03b9\u03bd\u03b4\u03cd\u03bd\u03bf\u03c5<\/strong>:\n<ul>\n<li>\u0395\u03bd\u03c3\u03c9\u03bc\u03b1\u03c4\u03ce\u03bd\u03b5\u03b9 \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b5\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03b1\u03bd\u03b1\u03b3\u03bd\u03ce\u03c1\u03b9\u03c3\u03b7, \u03b1\u03be\u03b9\u03bf\u03bb\u03cc\u03b3\u03b7\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03ad\u03bb\u03b5\u03b3\u03c7\u03bf \u03c4\u03c9\u03bd \u03ba\u03b9\u03bd\u03b4\u03cd\u03bd\u03c9\u03bd \u03c0\u03bf\u03c5 \u03c3\u03c7\u03b5\u03c4\u03af\u03b6\u03bf\u03bd\u03c4\u03b1\u03b9 \u03bc\u03b5 \u03c4\u03b1 \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ac \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03b1.<\/li>\n<li>\u03a0\u03b5\u03c1\u03b9\u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03b5\u03b9 \u03c4\u03b7\u03bd \u03b1\u03bd\u03ac\u03bb\u03c5\u03c3\u03b7 \u03ba\u03b9\u03bd\u03b4\u03cd\u03bd\u03bf\u03c5 \u03c3\u03b5 \u03cc\u03bb\u03b1 \u03c4\u03b1 \u03c3\u03c4\u03ac\u03b4\u03b9\u03b1 \u03c4\u03bf\u03c5 \u03ba\u03cd\u03ba\u03bb\u03bf\u03c5 \u03b6\u03c9\u03ae\u03c2 \u03c4\u03bf\u03c5 \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03bf\u03c2, \u03b1\u03c0\u03cc \u03c4\u03b7\u03bd \u03b1\u03bd\u03ac\u03c0\u03c4\u03c5\u03be\u03b7 \u03bc\u03ad\u03c7\u03c1\u03b9 \u03c4\u03b7\u03bd \u03b1\u03c0\u03cc\u03c3\u03c5\u03c1\u03c3\u03b7.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol start=\"2\">\n<li><strong>\u03a3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03bc\u03b5 \u039d\u03bf\u03bc\u03bf\u03b8\u03b5\u03c4\u03b9\u03ba\u03ad\u03c2 \u0391\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2<\/strong>:\n<ul>\n<li>\u0395\u03be\u03b1\u03c3\u03c6\u03b1\u03bb\u03af\u03b6\u03b5\u03b9 \u03cc\u03c4\u03b9 \u03c4\u03b1 \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03b1 \u03c0\u03bb\u03b7\u03c1\u03bf\u03cd\u03bd \u03c4\u03b9\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03c9\u03bd \u03ba\u03b1\u03bd\u03bf\u03bd\u03b9\u03c3\u03bc\u03ce\u03bd \u03ba\u03b1\u03b9 \u03c4\u03c9\u03bd \u03c0\u03c1\u03bf\u03c4\u03cd\u03c0\u03c9\u03bd \u03c0\u03bf\u03c5 \u03b9\u03c3\u03c7\u03cd\u03bf\u03c5\u03bd \u03c3\u03c4\u03b9\u03c2 \u03b1\u03b3\u03bf\u03c1\u03ad\u03c2 \u03cc\u03c0\u03bf\u03c5 \u03b4\u03b9\u03b1\u03c4\u03af\u03b8\u03b5\u03bd\u03c4\u03b1\u03b9.<\/li>\n<li>\u03a0\u03b5\u03c1\u03b9\u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03b5\u03b9 \u03c4\u03b7\u03bd \u03c0\u03b1\u03c1\u03b1\u03ba\u03bf\u03bb\u03bf\u03cd\u03b8\u03b7\u03c3\u03b7 \u03c4\u03c9\u03bd \u03b1\u03bb\u03bb\u03b1\u03b3\u03ce\u03bd \u03c3\u03c4\u03b7 \u03bd\u03bf\u03bc\u03bf\u03b8\u03b5\u03c3\u03af\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03c0\u03c1\u03bf\u03c3\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03c4\u03c9\u03bd \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03b9\u03ce\u03bd \u03c4\u03b7\u03c2 \u03b5\u03c4\u03b1\u03b9\u03c1\u03b5\u03af\u03b1\u03c2.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol start=\"3\">\n<li><strong>\u0399\u03ba\u03b1\u03bd\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03a0\u03b5\u03bb\u03b1\u03c4\u03ce\u03bd<\/strong>:\n<ul>\n<li>\u0395\u03c3\u03c4\u03b9\u03ac\u03b6\u03b5\u03b9 \u03c3\u03c4\u03b7 \u03c3\u03c5\u03bd\u03b5\u03c7\u03ae \u03bc\u03ad\u03c4\u03c1\u03b7\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03b2\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7 \u03c4\u03b7\u03c2 \u03b9\u03ba\u03b1\u03bd\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7\u03c2 \u03c4\u03c9\u03bd \u03c0\u03b5\u03bb\u03b1\u03c4\u03ce\u03bd.<\/li>\n<li>\u03a0\u03b5\u03c1\u03b9\u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03b5\u03b9 \u03c4\u03b7 \u03c3\u03c5\u03bb\u03bb\u03bf\u03b3\u03ae \u03ba\u03b1\u03b9 \u03b1\u03bd\u03ac\u03bb\u03c5\u03c3\u03b7 \u03b1\u03bd\u03b1\u03c4\u03c1\u03bf\u03c6\u03bf\u03b4\u03cc\u03c4\u03b7\u03c3\u03b7\u03c2 \u03b1\u03c0\u03cc \u03c4\u03bf\u03c5\u03c2 \u03c0\u03b5\u03bb\u03ac\u03c4\u03b5\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b7 \u03b2\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7 \u03c4\u03c9\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd \u03ba\u03b1\u03b9 \u03c4\u03c9\u03bd \u03c5\u03c0\u03b7\u03c1\u03b5\u03c3\u03b9\u03ce\u03bd.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol start=\"4\">\n<li><strong>\u0391\u03c3\u03c6\u03ac\u03bb\u03b5\u03b9\u03b1 \u03a0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd<\/strong>:\n<ul>\n<li>\u0394\u03b9\u03b1\u03c3\u03c6\u03b1\u03bb\u03af\u03b6\u03b5\u03b9 \u03cc\u03c4\u03b9 \u03c4\u03b1 \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03b1 \u03b5\u03af\u03bd\u03b1\u03b9 \u03b1\u03c3\u03c6\u03b1\u03bb\u03ae \u03b3\u03b9\u03b1 \u03c7\u03c1\u03ae\u03c3\u03b7 \u03b1\u03c0\u03cc \u03c4\u03bf\u03c5\u03c2 \u03b1\u03c3\u03b8\u03b5\u03bd\u03b5\u03af\u03c2 \u03ba\u03b1\u03b9 \u03c4\u03bf\u03c5\u03c2 \u03b5\u03c0\u03b1\u03b3\u03b3\u03b5\u03bb\u03bc\u03b1\u03c4\u03af\u03b5\u03c2 \u03c5\u03b3\u03b5\u03af\u03b1\u03c2.<\/li>\n<li>\u03a0\u03b5\u03c1\u03b9\u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03b5\u03b9 \u03c4\u03b7\u03bd \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03b1\u03c5\u03c3\u03c4\u03b7\u03c1\u03ce\u03bd \u03b5\u03bb\u03ad\u03b3\u03c7\u03c9\u03bd \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03ba\u03b1\u03b9 \u03b4\u03bf\u03ba\u03b9\u03bc\u03ce\u03bd \u03b1\u03c3\u03c6\u03b1\u03bb\u03b5\u03af\u03b1\u03c2.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<p>\u0391\u03c5\u03c4\u03ac \u03c4\u03b1 \u03c7\u03b1\u03c1\u03b1\u03ba\u03c4\u03b7\u03c1\u03b9\u03c3\u03c4\u03b9\u03ba\u03ac \u03ba\u03b1\u03b8\u03b9\u03c3\u03c4\u03bf\u03cd\u03bd \u03c4\u03bf ISO 13485:2016 \u03ad\u03bd\u03b1\u03bd \u03bf\u03bb\u03bf\u03ba\u03bb\u03b7\u03c1\u03c9\u03bc\u03ad\u03bd\u03bf \u03bf\u03b4\u03b7\u03b3\u03cc \u03b3\u03b9\u03b1 \u03c4\u03b7 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03c3\u03c4\u03bf\u03bd \u03c4\u03bf\u03bc\u03ad\u03b1 \u03c4\u03c9\u03bd \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd, \u03b5\u03be\u03b1\u03c3\u03c6\u03b1\u03bb\u03af\u03b6\u03bf\u03bd\u03c4\u03b1\u03c2 \u03c4\u03b7\u03bd \u03b1\u03c3\u03c6\u03ac\u03bb\u03b5\u03b9\u03b1, \u03c4\u03b7\u03bd \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b7 \u03c3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03bc\u03b5 \u03c4\u03bf\u03c5\u03c2 \u03ba\u03b1\u03bd\u03bf\u03bd\u03b9\u03c3\u03bc\u03bf\u03cd\u03c2 \u03c3\u03b5 \u03cc\u03bb\u03bf \u03c4\u03bf\u03bd \u03ba\u03cd\u03ba\u03bb\u03bf \u03b6\u03c9\u03ae\u03c2 \u03c4\u03c9\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd.<\/p>\n<h3><strong>\u03a0\u03bf\u03b9\u03b1 \u03b5\u03af\u03bd\u03b1\u03b9 \u03c4\u03b1 \u03bf\u03c6\u03ad\u03bb\u03b7 \u03b1\u03c0\u03cc \u03c4\u03b7\u03bd \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03c3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 \u03ba\u03b1\u03c4\u03ac <a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a>;<\/strong><\/h3>\n<p>\u03a4\u03bf \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf <strong>ISO 13485:2016<\/strong> \u03c0\u03b1\u03c1\u03ad\u03c7\u03b5\u03b9 \u03c0\u03bf\u03bb\u03bb\u03ac \u03ba\u03b1\u03b9 \u03c3\u03b7\u03bc\u03b1\u03bd\u03c4\u03b9\u03ba\u03ac \u03bf\u03c6\u03ad\u03bb\u03b7 \u03b3\u03b9\u03b1 \u03bf\u03c1\u03b3\u03b1\u03bd\u03b9\u03c3\u03bc\u03bf\u03cd\u03c2 \u03c0\u03bf\u03c5 \u03b1\u03c3\u03c7\u03bf\u03bb\u03bf\u03cd\u03bd\u03c4\u03b1\u03b9 \u03bc\u03b5 \u03c4\u03b7\u03bd \u03b1\u03bd\u03ac\u03c0\u03c4\u03c5\u03be\u03b7, \u03c4\u03b7\u03bd \u03ba\u03b1\u03c4\u03b1\u03c3\u03ba\u03b5\u03c5\u03ae \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03c0\u03b1\u03c1\u03bf\u03c7\u03ae \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd. \u0391\u03ba\u03bf\u03bb\u03bf\u03c5\u03b8\u03bf\u03cd\u03bd \u03c4\u03b1 \u03ba\u03cd\u03c1\u03b9\u03b1 \u03bf\u03c6\u03ad\u03bb\u03b7 \u03c4\u03b7\u03c2 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7\u03c2 \u03ba\u03b1\u03c4\u03ac <a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a><\/p>\n<ol>\n<li><strong> \u0392\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7 \u03c4\u03b7\u03c2 \u03a0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03a0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd<\/strong><\/li>\n<\/ol>\n<ul>\n<li>\u0397 \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03c4\u03bf\u03c5 \u03c0\u03c1\u03bf\u03c4\u03cd\u03c0\u03bf\u03c5 \u03c3\u03c5\u03bc\u03b2\u03ac\u03bb\u03bb\u03b5\u03b9 \u03c3\u03c4\u03b7 \u03c3\u03c5\u03c3\u03c4\u03b7\u03bc\u03b1\u03c4\u03b9\u03ba\u03ae \u03c0\u03c1\u03bf\u03c3\u03ad\u03b3\u03b3\u03b9\u03c3\u03b7 \u03b3\u03b9\u03b1 \u03c4\u03b7 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2, \u03b5\u03be\u03b1\u03c3\u03c6\u03b1\u03bb\u03af\u03b6\u03bf\u03bd\u03c4\u03b1\u03c2 \u03cc\u03c4\u03b9 \u03c4\u03b1 \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ac \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03b1 \u03c0\u03bb\u03b7\u03c1\u03bf\u03cd\u03bd \u03c4\u03b9\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03ba\u03b1\u03b9 \u03b1\u03c3\u03c6\u03ac\u03bb\u03b5\u03b9\u03b1\u03c2.<\/li>\n<li>\u0394\u03b9\u03b5\u03c5\u03ba\u03bf\u03bb\u03cd\u03bd\u03b5\u03b9 \u03c4\u03b7\u03bd \u03b1\u03bd\u03af\u03c7\u03bd\u03b5\u03c5\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03b1\u03c0\u03bf\u03b4\u03bf\u03c7\u03ae \u03c4\u03c9\u03bd \u03bc\u03b7 \u03c3\u03c5\u03bc\u03bc\u03bf\u03c1\u03c6\u03ce\u03c3\u03b5\u03c9\u03bd, \u03b5\u03bd\u03b9\u03c3\u03c7\u03cd\u03bf\u03bd\u03c4\u03b1\u03c2 \u03c4\u03b7 \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b1 \u03b5\u03bb\u03ad\u03b3\u03c7\u03bf\u03c5 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2.<\/li>\n<\/ul>\n<ol start=\"2\">\n<li><strong> \u03a3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03bc\u03b5 \u039a\u03b1\u03bd\u03bf\u03bd\u03b9\u03c3\u03c4\u03b9\u03ba\u03ad\u03c2 \u0391\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2<\/strong><\/li>\n<\/ol>\n<ul>\n<li>\u0392\u03bf\u03b7\u03b8\u03ac \u03c4\u03b9\u03c2 \u03bf\u03c1\u03b3\u03b1\u03bd\u03ce\u03c3\u03b5\u03b9\u03c2 \u03bd\u03b1 \u03c3\u03c5\u03bc\u03bc\u03bf\u03c1\u03c6\u03ce\u03bd\u03bf\u03bd\u03c4\u03b1\u03b9 \u03bc\u03b5 \u03c4\u03b9\u03c2 \u03c1\u03c5\u03b8\u03bc\u03b9\u03c3\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03ba\u03b1\u03b9 \u03c4\u03b1 \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03b1 \u03c0\u03bf\u03c5 \u03c3\u03c7\u03b5\u03c4\u03af\u03b6\u03bf\u03bd\u03c4\u03b1\u03b9 \u03bc\u03b5 \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ac \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03b1, \u03b5\u03bd\u03b9\u03c3\u03c7\u03cd\u03bf\u03bd\u03c4\u03b1\u03c2 \u03c4\u03b7\u03bd \u03b5\u03bc\u03c0\u03b9\u03c3\u03c4\u03bf\u03c3\u03cd\u03bd\u03b7 \u03c4\u03c9\u03bd \u03b5\u03bd\u03b4\u03b9\u03b1\u03c6\u03b5\u03c1\u03cc\u03bc\u03b5\u03bd\u03c9\u03bd \u03bc\u03b5\u03c1\u03ce\u03bd.<\/li>\n<li>\u0394\u03b9\u03b5\u03c5\u03ba\u03bf\u03bb\u03cd\u03bd\u03b5\u03b9 \u03c4\u03b7 \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b1 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7\u03c2 \u03b1\u03c0\u03cc \u03c4\u03b9\u03c2 \u03c1\u03c5\u03b8\u03bc\u03b9\u03c3\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b1\u03c1\u03c7\u03ad\u03c2.<\/li>\n<\/ul>\n<ol start=\"3\">\n<li><strong> \u0391\u03cd\u03be\u03b7\u03c3\u03b7 \u0399\u03ba\u03b1\u03bd\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7\u03c2 \u03a0\u03b5\u03bb\u03b1\u03c4\u03ce\u03bd<\/strong><\/li>\n<\/ol>\n<ul>\n<li>\u0397 \u03c3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03bc\u03b5 \u03c4\u03bf <strong>ISO 13485<\/strong> \u03b5\u03bd\u03b9\u03c3\u03c7\u03cd\u03b5\u03b9 \u03c4\u03b7\u03bd \u03b5\u03bc\u03c0\u03b9\u03c3\u03c4\u03bf\u03c3\u03cd\u03bd\u03b7 \u03c4\u03c9\u03bd \u03c0\u03b5\u03bb\u03b1\u03c4\u03ce\u03bd, \u03ba\u03b1\u03b8\u03ce\u03c2 \u03b4\u03b9\u03b1\u03c3\u03c6\u03b1\u03bb\u03af\u03b6\u03b5\u03b9 \u03cc\u03c4\u03b9 \u03c4\u03b1 \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03b1 \u03b5\u03af\u03bd\u03b1\u03b9 \u03b1\u03c3\u03c6\u03b1\u03bb\u03ae \u03ba\u03b1\u03b9 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03c3\u03bc\u03b1\u03c4\u03b9\u03ba\u03ac.<\/li>\n<li>\u0397 \u03b9\u03ba\u03b1\u03bd\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03c4\u03c9\u03bd \u03c0\u03b5\u03bb\u03b1\u03c4\u03ce\u03bd \u03bc\u03c0\u03bf\u03c1\u03b5\u03af \u03bd\u03b1 \u03b1\u03c5\u03be\u03b7\u03b8\u03b5\u03af \u03bc\u03ad\u03c3\u03c9 \u03c4\u03b7\u03c2 \u03c4\u03b1\u03ba\u03c4\u03b9\u03ba\u03ae\u03c2 \u03b1\u03bd\u03b1\u03c4\u03c1\u03bf\u03c6\u03bf\u03b4\u03cc\u03c4\u03b7\u03c3\u03b7\u03c2 \u03ba\u03b1\u03b9 \u03b2\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7\u03c2 \u03c4\u03b7\u03c2 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2.<\/li>\n<\/ul>\n<ol start=\"4\">\n<li><strong> \u03a3\u03c5\u03bd\u03b5\u03c7\u03ae\u03c2 \u0392\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7<\/strong><\/li>\n<\/ol>\n<ul>\n<li>\u03a4\u03bf \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf \u03c0\u03c1\u03bf\u03ac\u03b3\u03b5\u03b9 \u03c4\u03b7\u03bd \u03ba\u03bf\u03c5\u03bb\u03c4\u03bf\u03cd\u03c1\u03b1 \u03c4\u03b7\u03c2 \u03c3\u03c5\u03bd\u03b5\u03c7\u03bf\u03cd\u03c2 \u03b2\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7\u03c2 \u03bc\u03ad\u03c3\u03c9 \u03c4\u03b7\u03c2 \u03b1\u03be\u03b9\u03bf\u03bb\u03cc\u03b3\u03b7\u03c3\u03b7\u03c2 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03c2 \u03b1\u03bd\u03ac\u03bb\u03c5\u03c3\u03b7\u03c2 \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03b9\u03ce\u03bd, \u03b5\u03bd\u03b8\u03b1\u03c1\u03c1\u03cd\u03bd\u03bf\u03bd\u03c4\u03b1\u03c2 \u03c4\u03b9\u03c2 \u03bf\u03c1\u03b3\u03b1\u03bd\u03ce\u03c3\u03b5\u03b9\u03c2 \u03bd\u03b1 \u03b1\u03bd\u03b1\u03b3\u03bd\u03c9\u03c1\u03af\u03b6\u03bf\u03c5\u03bd \u03b5\u03c5\u03ba\u03b1\u03b9\u03c1\u03af\u03b5\u03c2 \u03b3\u03b9\u03b1 \u03b2\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7.<\/li>\n<li>\u0394\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b5\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03b1\u03bd\u03af\u03c7\u03bd\u03b5\u03c5\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03c4\u03b7 \u03b4\u03b9\u03cc\u03c1\u03b8\u03c9\u03c3\u03b7 \u03bc\u03b7 \u03c3\u03c5\u03bc\u03bc\u03bf\u03c1\u03c6\u03ce\u03c3\u03b5\u03c9\u03bd \u03b5\u03bd\u03b9\u03c3\u03c7\u03cd\u03bf\u03c5\u03bd \u03c4\u03b7\u03bd \u03c0\u03c1\u03cc\u03bb\u03b7\u03c8\u03b7 \u03c0\u03c1\u03bf\u03b2\u03bb\u03b7\u03bc\u03ac\u03c4\u03c9\u03bd.<\/li>\n<\/ul>\n<ol start=\"5\">\n<li><strong> \u039c\u03b5\u03af\u03c9\u03c3\u03b7 \u039a\u03b9\u03bd\u03b4\u03cd\u03bd\u03c9\u03bd<\/strong><\/li>\n<\/ol>\n<ul>\n<li>\u0397 \u03b5\u03bd\u03c3\u03c9\u03bc\u03ac\u03c4\u03c9\u03c3\u03ae \u03c4\u03b7\u03c2 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u03ba\u03b9\u03bd\u03b4\u03cd\u03bd\u03c9\u03bd \u03c3\u03c4\u03bf \u03a3\u0394\u03a0 \u03b2\u03bf\u03b7\u03b8\u03ac \u03c3\u03c4\u03b7\u03bd \u03b1\u03bd\u03b1\u03b3\u03bd\u03ce\u03c1\u03b9\u03c3\u03b7, \u03c4\u03b7\u03bd \u03b1\u03be\u03b9\u03bf\u03bb\u03cc\u03b3\u03b7\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03b5\u03bb\u03b1\u03c7\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03c4\u03c9\u03bd \u03ba\u03b9\u03bd\u03b4\u03cd\u03bd\u03c9\u03bd \u03c0\u03bf\u03c5 \u03c3\u03c7\u03b5\u03c4\u03af\u03b6\u03bf\u03bd\u03c4\u03b1\u03b9 \u03bc\u03b5 \u03c4\u03b7\u03bd \u03b1\u03c3\u03c6\u03ac\u03bb\u03b5\u03b9\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03b1\u03c0\u03cc\u03b4\u03bf\u03c3\u03b7 \u03c4\u03c9\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd.<\/li>\n<li>\u0392\u03b5\u03bb\u03c4\u03b9\u03ce\u03bd\u03b5\u03b9 \u03c4\u03b7\u03bd \u03b1\u03bd\u03b8\u03b5\u03ba\u03c4\u03b9\u03ba\u03cc\u03c4\u03b7\u03c4\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b7 \u03b2\u03b9\u03c9\u03c3\u03b9\u03bc\u03cc\u03c4\u03b7\u03c4\u03b1 \u03c4\u03c9\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd \u03c3\u03b5 \u03c3\u03c5\u03bd\u03b8\u03ae\u03ba\u03b5\u03c2 \u03b1\u03b3\u03bf\u03c1\u03ac\u03c2 \u03c0\u03bf\u03c5 \u03b1\u03bb\u03bb\u03ac\u03b6\u03bf\u03c5\u03bd.<\/li>\n<\/ul>\n<ol start=\"6\">\n<li><strong> \u0394\u03b9\u03b1\u03c6\u03bf\u03c1\u03b5\u03c4\u03b9\u03ba\u03cc\u03c4\u03b7\u03c4\u03b1 \u03c3\u03c4\u03b7\u03bd \u0391\u03b3\u03bf\u03c1\u03ac<\/strong><\/li>\n<\/ol>\n<ul>\n<li>\u0397 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03ba\u03b1\u03c4\u03ac <a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a> \u03bc\u03c0\u03bf\u03c1\u03b5\u03af \u03bd\u03b1 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03ad\u03c3\u03b5\u03b9 \u03b1\u03bd\u03c4\u03b1\u03b3\u03c9\u03bd\u03b9\u03c3\u03c4\u03b9\u03ba\u03cc \u03c0\u03bb\u03b5\u03bf\u03bd\u03ad\u03ba\u03c4\u03b7\u03bc\u03b1, \u03ba\u03b1\u03b8\u03ce\u03c2 \u03bf\u03b9 \u03bf\u03c1\u03b3\u03b1\u03bd\u03b9\u03c3\u03bc\u03bf\u03af \u03bc\u03b5 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03ad\u03c7\u03bf\u03c5\u03bd \u03c0\u03b5\u03c1\u03b9\u03c3\u03c3\u03cc\u03c4\u03b5\u03c1\u03b5\u03c2 \u03c0\u03b9\u03b8\u03b1\u03bd\u03cc\u03c4\u03b7\u03c4\u03b5\u03c2 \u03bd\u03b1 \u03c0\u03c1\u03bf\u03c3\u03b5\u03bb\u03ba\u03cd\u03c3\u03bf\u03c5\u03bd \u03bd\u03ad\u03bf\u03c5\u03c2 \u03c0\u03b5\u03bb\u03ac\u03c4\u03b5\u03c2 \u03ba\u03b1\u03b9 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03ac\u03c4\u03b5\u03c2.<\/li>\n<li>\u0394\u03b7\u03bc\u03b9\u03bf\u03c5\u03c1\u03b3\u03b5\u03af \u03c4\u03b7\u03bd \u03b5\u03c5\u03ba\u03b1\u03b9\u03c1\u03af\u03b1 \u03b3\u03b9\u03b1 \u03b5\u03c0\u03ad\u03ba\u03c4\u03b1\u03c3\u03b7 \u03c3\u03b5 \u03b4\u03b9\u03b5\u03b8\u03bd\u03b5\u03af\u03c2 \u03b1\u03b3\u03bf\u03c1\u03ad\u03c2, \u03ba\u03b1\u03b8\u03ce\u03c2 \u03bf\u03b9 \u03c0\u03b5\u03bb\u03ac\u03c4\u03b5\u03c2 \u03c3\u03c5\u03c7\u03bd\u03ac \u03c0\u03c1\u03bf\u03c4\u03b9\u03bc\u03bf\u03cd\u03bd \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1 \u03bc\u03b5 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03b9\u03b7\u03bc\u03ad\u03bd\u03bf\u03c5\u03c2 \u03c0\u03c1\u03bf\u03bc\u03b7\u03b8\u03b5\u03c5\u03c4\u03ad\u03c2.<\/li>\n<\/ul>\n<ol start=\"7\">\n<li><strong> \u0391\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03c3\u03bc\u03b1\u03c4\u03b9\u03ba\u03cc\u03c4\u03b7\u03c4\u03b1 \u03ba\u03b1\u03b9 \u0391\u03c0\u03bf\u03b4\u03bf\u03c4\u03b9\u03ba\u03cc\u03c4\u03b7\u03c4\u03b1<\/strong><\/li>\n<\/ol>\n<ul>\n<li>\u0397 \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03c3\u03c5\u03c3\u03c4\u03b7\u03bc\u03b1\u03c4\u03b9\u03ba\u03ce\u03bd \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03b9\u03ce\u03bd \u03b2\u03bf\u03b7\u03b8\u03ac \u03c3\u03c4\u03b7 \u03bc\u03b5\u03af\u03c9\u03c3\u03b7 \u03c4\u03c9\u03bd \u03b1\u03c0\u03bf\u03b2\u03bb\u03ae\u03c4\u03c9\u03bd \u03ba\u03b1\u03b9 \u03c4\u03c9\u03bd \u03b1\u03bd\u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03c3\u03bc\u03b1\u03c4\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03b1\u03ba\u03c4\u03b9\u03ba\u03ce\u03bd, \u03bf\u03b4\u03b7\u03b3\u03ce\u03bd\u03c4\u03b1\u03c2 \u03c3\u03b5 \u03bf\u03b9\u03ba\u03bf\u03bd\u03bf\u03bc\u03af\u03b5\u03c2 \u03ba\u03cc\u03c3\u03c4\u03bf\u03c5\u03c2.<\/li>\n<li>\u039f\u03b9 \u03c3\u03b1\u03c6\u03b5\u03af\u03c2 \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b5\u03c2 \u03ba\u03b1\u03b9 \u03bf\u03b9 \u03c1\u03cc\u03bb\u03bf\u03b9 \u03b4\u03b9\u03b5\u03c5\u03ba\u03bf\u03bb\u03cd\u03bd\u03bf\u03c5\u03bd \u03c4\u03b7 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03c4\u03b7 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1 \u03c4\u03c9\u03bd \u03bf\u03bc\u03ac\u03b4\u03c9\u03bd.<\/li>\n<\/ul>\n<ol start=\"8\">\n<li><strong> \u039a\u03b1\u03bb\u03cd\u03c4\u03b5\u03c1\u03b7 \u0394\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u03a0\u03cc\u03c1\u03c9\u03bd<\/strong><\/li>\n<\/ol>\n<ul>\n<li>\u0392\u03bf\u03b7\u03b8\u03ac \u03c3\u03c4\u03b7\u03bd \u03ba\u03b1\u03bb\u03cd\u03c4\u03b5\u03c1\u03b7 \u03ba\u03b1\u03c4\u03b1\u03bd\u03bf\u03bc\u03ae \u03ba\u03b1\u03b9 \u03c7\u03c1\u03ae\u03c3\u03b7 \u03c4\u03c9\u03bd \u03c0\u03cc\u03c1\u03c9\u03bd, \u03b5\u03be\u03b1\u03c3\u03c6\u03b1\u03bb\u03af\u03b6\u03bf\u03bd\u03c4\u03b1\u03c2 \u03cc\u03c4\u03b9 \u03bf\u03b9 \u03b1\u03c0\u03b1\u03b9\u03c4\u03bf\u03cd\u03bc\u03b5\u03bd\u03bf\u03b9 \u03c0\u03cc\u03c1\u03bf\u03b9 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03c0\u03b1\u03c1\u03b1\u03b3\u03c9\u03b3\u03ae \u03ba\u03b1\u03b9 \u03c4\u03b7 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03b5\u03af\u03bd\u03b1\u03b9 \u03b4\u03b9\u03b1\u03b8\u03ad\u03c3\u03b9\u03bc\u03bf\u03b9 \u03ba\u03b1\u03b9 \u03b5\u03c0\u03b1\u03c1\u03ba\u03b5\u03af\u03c2.<\/li>\n<li>\u0397 \u03b5\u03ba\u03c0\u03b1\u03af\u03b4\u03b5\u03c5\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03b7 \u03b1\u03bd\u03ac\u03c0\u03c4\u03c5\u03be\u03b7 \u03c4\u03bf\u03c5 \u03c0\u03c1\u03bf\u03c3\u03c9\u03c0\u03b9\u03ba\u03bf\u03cd \u03bf\u03b4\u03b7\u03b3\u03bf\u03cd\u03bd \u03c3\u03b5 \u03ba\u03b1\u03bb\u03cd\u03c4\u03b5\u03c1\u03b5\u03c2 \u03b5\u03c0\u03b9\u03b4\u03cc\u03c3\u03b5\u03b9\u03c2 \u03ba\u03b1\u03b9 \u03b9\u03ba\u03b1\u03bd\u03cc\u03c4\u03b7\u03c4\u03b5\u03c2.<\/li>\n<\/ul>\n<ol start=\"9\">\n<li><strong> \u0391\u03c5\u03be\u03b7\u03bc\u03ad\u03bd\u03b7 \u03a6\u03ae\u03bc\u03b7 \u03ba\u03b1\u03b9 \u0395\u03bc\u03c0\u03b9\u03c3\u03c4\u03bf\u03c3\u03cd\u03bd\u03b7<\/strong><\/li>\n<\/ol>\n<ul>\n<li>\u0397 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03ba\u03b1\u03c4\u03ac <a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a> \u03c3\u03c5\u03bc\u03b2\u03ac\u03bb\u03bb\u03b5\u03b9 \u03c3\u03c4\u03b7 \u03b8\u03b5\u03c4\u03b9\u03ba\u03ae \u03b5\u03b9\u03ba\u03cc\u03bd\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b7 \u03c6\u03ae\u03bc\u03b7 \u03c4\u03b7\u03c2 \u03b5\u03c0\u03b9\u03c7\u03b5\u03af\u03c1\u03b7\u03c3\u03b7\u03c2, \u03b5\u03bd\u03b9\u03c3\u03c7\u03cd\u03bf\u03bd\u03c4\u03b1\u03c2 \u03c4\u03b7\u03bd \u03b5\u03bc\u03c0\u03b9\u03c3\u03c4\u03bf\u03c3\u03cd\u03bd\u03b7 \u03c4\u03c9\u03bd \u03c0\u03b5\u03bb\u03b1\u03c4\u03ce\u03bd \u03ba\u03b1\u03b9 \u03c4\u03c9\u03bd \u03b5\u03bd\u03b4\u03b9\u03b1\u03c6\u03b5\u03c1\u03cc\u03bc\u03b5\u03bd\u03c9\u03bd \u03bc\u03b5\u03c1\u03ce\u03bd.<\/li>\n<li>\u0397 \u03b9\u03ba\u03b1\u03bd\u03cc\u03c4\u03b7\u03c4\u03b1 \u03bd\u03b1 \u03b1\u03c0\u03bf\u03b4\u03b5\u03af\u03be\u03b5\u03c4\u03b5 \u03c4\u03b7\u03bd \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1 \u03c4\u03c9\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd \u03ba\u03b1\u03b9 \u03c4\u03b7 \u03b4\u03ad\u03c3\u03bc\u03b5\u03c5\u03c3\u03b7 \u03b3\u03b9\u03b1 \u03c3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03b5\u03bd\u03b9\u03c3\u03c7\u03cd\u03b5\u03b9 \u03c4\u03b7 \u03c6\u03ae\u03bc\u03b7 \u03c3\u03c4\u03bf\u03bd \u03c4\u03bf\u03bc\u03ad\u03b1 \u03c4\u03c9\u03bd \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd.<\/li>\n<\/ul>\n<ol start=\"10\">\n<li><strong> \u0394\u03b9\u03b1\u03c1\u03ba\u03ae\u03c2 \u03a3\u03c7\u03ad\u03c3\u03b7 \u03bc\u03b5 \u03a1\u03c5\u03b8\u03bc\u03b9\u03c3\u03c4\u03b9\u03ba\u03ad\u03c2 \u0391\u03c1\u03c7\u03ad\u03c2<\/strong><\/li>\n<\/ol>\n<ul>\n<li>\u0397 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03b2\u03bf\u03b7\u03b8\u03ac \u03c3\u03c4\u03b7 \u03b4\u03b9\u03b1\u03c4\u03ae\u03c1\u03b7\u03c3\u03b7 \u03ba\u03b1\u03bb\u03ce\u03bd \u03c3\u03c7\u03ad\u03c3\u03b5\u03c9\u03bd \u03bc\u03b5 \u03c4\u03b9\u03c2 \u03c1\u03c5\u03b8\u03bc\u03b9\u03c3\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b1\u03c1\u03c7\u03ad\u03c2, \u03b4\u03b9\u03b5\u03c5\u03ba\u03bf\u03bb\u03cd\u03bd\u03bf\u03bd\u03c4\u03b1\u03c2 \u03c4\u03b7\u03bd \u03b5\u03c0\u03b9\u03ba\u03bf\u03b9\u03bd\u03c9\u03bd\u03af\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03c5\u03c0\u03bf\u03b2\u03bf\u03bb\u03ae \u03b5\u03ba\u03b8\u03ad\u03c3\u03b5\u03c9\u03bd.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>\u0397 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03ba\u03b1\u03c4\u03ac <strong>ISO 13485:2016<\/strong> \u03c0\u03c1\u03bf\u03c3\u03c6\u03ad\u03c1\u03b5\u03b9 \u03bc\u03b9\u03b1 \u03c3\u03b5\u03b9\u03c1\u03ac \u03b1\u03c0\u03cc \u03c3\u03c4\u03c1\u03b1\u03c4\u03b7\u03b3\u03b9\u03ba\u03ac \u03c0\u03bb\u03b5\u03bf\u03bd\u03b5\u03ba\u03c4\u03ae\u03bc\u03b1\u03c4\u03b1, \u03b2\u03b5\u03bb\u03c4\u03b9\u03ce\u03bd\u03bf\u03bd\u03c4\u03b1\u03c2 \u03c4\u03b7\u03bd \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1 \u03c4\u03c9\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd, \u03c4\u03b7 \u03c3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03bc\u03b5 \u03ba\u03b1\u03bd\u03bf\u03bd\u03b9\u03c3\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03b9\u03ba\u03b1\u03bd\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03c4\u03c9\u03bd \u03c0\u03b5\u03bb\u03b1\u03c4\u03ce\u03bd, \u03b5\u03bd\u03ce \u03c0\u03b1\u03c1\u03ac\u03bb\u03bb\u03b7\u03bb\u03b1 \u03c0\u03c1\u03bf\u03ac\u03b3\u03b5\u03b9 \u03c4\u03b7 \u03c3\u03c5\u03bd\u03b5\u03c7\u03ae \u03b2\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03c3\u03bc\u03b1\u03c4\u03b9\u03ba\u03cc\u03c4\u03b7\u03c4\u03b1. \u0391\u03c5\u03c4\u03ac \u03c4\u03b1 \u03bf\u03c6\u03ad\u03bb\u03b7 \u03ba\u03b1\u03b8\u03b9\u03c3\u03c4\u03bf\u03cd\u03bd \u03c4\u03b7\u03bd \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03ba\u03b1\u03c4\u03ac <strong>ISO 13485<\/strong> \u03b1\u03bd\u03b1\u03b3\u03ba\u03b1\u03af\u03b1 \u03b3\u03b9\u03b1 \u03bf\u03c1\u03b3\u03b1\u03bd\u03b9\u03c3\u03bc\u03bf\u03cd\u03c2 \u03c0\u03bf\u03c5 \u03b4\u03c1\u03b1\u03c3\u03c4\u03b7\u03c1\u03b9\u03bf\u03c0\u03bf\u03b9\u03bf\u03cd\u03bd\u03c4\u03b1\u03b9 \u03c3\u03c4\u03bf\u03bd \u03c4\u03bf\u03bc\u03ad\u03b1 \u03c4\u03c9\u03bd \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u0393\u03b9\u03b1\u03c4\u03af \u03c3\u03b5 \u03b5\u03bc\u03ac\u03c2; \u0388\u03c7\u03bf\u03bd\u03c4\u03b1\u03c2 \u03c3\u03c7\u03b5\u03b4\u03cc\u03bd 25 \u03c7\u03c1\u03cc\u03bd\u03b9\u03b1 \u03b5\u03bc\u03c0\u03b5\u03b9\u03c1\u03af\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b5\u03c7\u03bd\u03bf\u03b3\u03bd\u03c9\u03c3\u03af\u03b1 \u03c3\u03c4\u03bf\u03bd \u03c3\u03c5\u03b3\u03ba\u03b5\u03ba\u03c1\u03b9\u03bc\u03ad\u03bd\u03bf \u03c7\u03ce\u03c1\u03bf \u03c4\u03c9\u03bd \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd \u03ba\u03b1\u03b9 \u03ad\u03c7\u03bf\u03bd\u03c4\u03b1\u03c2 \u03bc\u03ad\u03c7\u03c1\u03b9 \u03c3\u03ae\u03bc\u03b5\u03c1\u03b1 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03b9\u03ae\u03c3\u03b5\u03b9 \u03c0\u03ac\u03bd\u03c9 \u03b1\u03c0\u03cc 80 \u03a3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03b1 \u03a0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03c9\u03c2 \u03c0\u03c1\u03bf\u03c2 \u03c4\u03bf ISO 13485 \u03c3\u03b5 \u03cc\u03bb\u03b5\u03c2 \u03c4\u03b9\u03c2 \u03bc\u03bf\u03c1\u03c6\u03ad\u03c2 \u03b4\u03c1\u03b1\u03c3\u03c4\u03b7\u03c1\u03b9\u03bf\u03c4\u03ae\u03c4\u03c9\u03bd (\u03c0\u03b1\u03c1\u03b1\u03b3\u03c9\u03b3\u03ae, \u03b5\u03bc\u03c0\u03bf\u03c1\u03af\u03b1, \u03c4\u03b5\u03c7\u03bd\u03b9\u03ba\u03ae \u03c5\u03c0\u03bf\u03c3\u03c4\u03ae\u03c1\u03b9\u03be\u03b7), \u03bc\u03b1\u03c2 \u03ba\u03ac\u03bd\u03b5\u03b9 \u03c4\u03bf\u03c5\u03c2 \u03b9\u03b4\u03b1\u03bd\u03b9\u03ba\u03cc\u03c4\u03b5\u03c1\u03bf\u03c5\u03c2 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03ac\u03c4\u03b5\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03b5\u03b3\u03ba\u03b1\u03c4\u03ac\u03c3\u03c4\u03b1\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03b1\u03c5\u03c4\u03ce\u03bd \u03c4\u03c9\u03bd \u03a3\u03c5\u03c3\u03c4\u03b7\u03bc\u03ac\u03c4\u03c9\u03bd. \u0397 \u03b5\u03bc\u03c0\u03b5\u03b9\u03c1\u03af\u03b1 &hellip; <a href=\"https:\/\/www.qualityinquality.gr\/?page_id=19\" class=\"more-link\">\u03a3\u03c5\u03bd\u03ad\u03c7\u03b5\u03b9\u03b1 \u03b1\u03bd\u03ac\u03b3\u03bd\u03c9\u03c3\u03b7\u03c2 <span class=\"screen-reader-text\">ISO 13485\/2016 (medical devices)<\/span> <span 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