{"id":14133,"date":"2026-07-07T13:01:26","date_gmt":"2026-07-07T11:01:26","guid":{"rendered":"https:\/\/www.nestor.com.gr\/?p=14133"},"modified":"2026-07-07T13:01:26","modified_gmt":"2026-07-07T11:01:26","slug":"iso-13485-iatrotexnologika-proionta","status":"publish","type":"post","link":"http:\/\/www.nestor.com.gr\/en\/blog\/iso-13485-iatrotexnologika-proionta\/","title":{"rendered":"ISO 13485 &#038; \u03a5\u0391 4822\/2025: \u039f\u03b4\u03b7\u03b3\u03cc\u03c2 \u03a3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7\u03c2 \u03b3\u03b9\u03b1 \u0399\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ac"},"content":{"rendered":"<p>\u039f \u03ba\u03bb\u03ac\u03b4\u03bf\u03c2 \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 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03af \u03ad\u03bd\u03b1\u03bd \u03b1\u03c0\u03cc \u03c4\u03bf\u03c5\u03c2 \u03c0\u03bb\u03ad\u03bf\u03bd \u03b1\u03c5\u03c3\u03c4\u03b7\u03c1\u03ac \u03c1\u03c5\u03b8\u03bc\u03b9\u03b6\u03cc\u03bc\u03b5\u03bd\u03bf\u03c5\u03c2 \u03c4\u03bf\u03bc\u03b5\u03af\u03c2 \u03c3\u03c4\u03b7\u03bd \u0395\u03c5\u03c1\u03ce\u03c0\u03b7 \u03ba\u03b1\u03b9 \u03b4\u03b9\u03b5\u03b8\u03bd\u03ce\u03c2. \u039f\u03b9 \u03b5\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\u03b5 \u03b1\u03c5\u03c4\u03cc\u03bd \u03ba\u03b1\u03bb\u03bf\u03cd\u03bd\u03c4\u03b1\u03b9 \u03bd\u03b1 \u03b1\u03c0\u03bf\u03b4\u03b5\u03b9\u03ba\u03bd\u03cd\u03bf\u03c5\u03bd \u03ba\u03b1\u03b8\u03b7\u03bc\u03b5\u03c1\u03b9\u03bd\u03ac \u03cc\u03c4\u03b9 \u03bb\u03b5\u03b9\u03c4\u03bf\u03c5\u03c1\u03b3\u03bf\u03cd\u03bd \u03bc\u03b5 \u03c0\u03bb\u03ae\u03c1\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. \u03a4\u03bf ISO 13485 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03af \u03c4\u03bf \u03b2\u03b1\u03c3\u03b9\u03ba\u03cc \u03b4\u03b9\u03b5\u03b8\u03bd\u03ad\u03c2 \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03b3\u03b9\u03b1 \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>\r\n<p><a href=\"http:\/\/www.nestor.com.gr\/en\/blog\/iso-13485-iatrotexnologika-proionta\/attachment\/pexels-mart-production-7088524\/\" rel=\"attachment wp-att-14134\"><img data-recalc-dims=\"1\" decoding=\"async\" class=\"wp-image-14134 aligncenter\" src=\"https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524.jpg?resize=575%2C384\" alt=\"ISO 13485\" width=\"575\" height=\"384\" srcset=\"https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=18%2C12&amp;ssl=1 18w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=200%2C133&amp;ssl=1 200w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=300%2C200&amp;ssl=1 300w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=400%2C267&amp;ssl=1 400w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=600%2C400&amp;ssl=1 600w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=768%2C512&amp;ssl=1 768w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=800%2C533&amp;ssl=1 800w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=1024%2C683&amp;ssl=1 1024w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=1200%2C800&amp;ssl=1 1200w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=1536%2C1024&amp;ssl=1 1536w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?resize=1800%2C1200&amp;ssl=1 1800w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?w=2200 2200w, https:\/\/i0.wp.com\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/pexels-mart-production-7088524-scaled.jpg?fit=2560%2C1707&amp;ssl=1 2560w\" sizes=\"(max-width: 575px) 100vw, 575px\" \/><\/a><\/p>\r\n<p>\u0397 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\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 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03af \u03c4\u03cc\u03c3\u03bf \u03b1\u03bd\u03c4\u03b1\u03b3\u03c9\u03bd\u03b9\u03c3\u03c4\u03b9\u03ba\u03cc \u03c0\u03bb\u03b5\u03bf\u03bd\u03ad\u03ba\u03c4\u03b7\u03bc\u03b1 \u03cc\u03c3\u03bf \u03ba\u03b1\u03b9 \u03bf\u03c5\u03c3\u03b9\u03b1\u03c3\u03c4\u03b9\u03ba\u03ae \u03c0\u03c1\u03bf\u03cb\u03c0\u03cc\u03b8\u03b5\u03c3\u03b7 \u03b3\u03b9\u03b1 \u03c4\u03b7 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1 \u03bc\u03b5 \u03bd\u03bf\u03c3\u03bf\u03ba\u03bf\u03bc\u03b5\u03af\u03b1, \u03c0\u03c1\u03bf\u03bc\u03b7\u03b8\u03b5\u03c5\u03c4\u03ad\u03c2, \u03b4\u03b7\u03bc\u03cc\u03c3\u03b9\u03bf\u03c5\u03c2 \u03c6\u03bf\u03c1\u03b5\u03af\u03c2 \u03ba\u03b1\u03b9 \u03b4\u03b9\u03b5\u03b8\u03bd\u03b5\u03af\u03c2 \u03b1\u03b3\u03bf\u03c1\u03ad\u03c2. \u03a0\u03b1\u03c1\u03ac\u03bb\u03bb\u03b7\u03bb\u03b1, \u03b7 \u03a5\u0391 \u03943(\u03b1)4822\/2025 \u03b5\u03bd\u03b9\u03c3\u03c7\u03cd\u03b5\u03b9 \u03b1\u03ba\u03cc\u03bc\u03b7 \u03c0\u03b5\u03c1\u03b9\u03c3\u03c3\u03cc\u03c4\u03b5\u03c1\u03bf \u03c4\u03b7\u03bd \u03b1\u03bd\u03ac\u03b3\u03ba\u03b7 \u03b3\u03b9\u03b1 \u03bf\u03c1\u03b3\u03b1\u03bd\u03c9\u03bc\u03ad\u03bd\u03b1 \u03ba\u03b1\u03b9 \u03c4\u03b5\u03ba\u03bc\u03b7\u03c1\u03b9\u03c9\u03bc\u03ad\u03bd\u03b1 \u03c3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03b1 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\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.<\/p>\r\n<h2><strong>\u03a4\u03b9 \u0395\u03af\u03bd\u03b1\u03b9 \u03c4\u03bf ISO 13485:2016<\/strong><\/h2>\r\n<p>\u03a4\u03bf ISO 13485:2016 \u03b5\u03af\u03bd\u03b1\u03b9 \u03c4\u03bf \u03b4\u03b9\u03b5\u03b8\u03bd\u03ad\u03c2 \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf \u03c0\u03bf\u03c5 \u03ba\u03b1\u03b8\u03bf\u03c1\u03af\u03b6\u03b5\u03b9 \u03c4\u03b9\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03b1\u03bd\u03ac\u03c0\u03c4\u03c5\u03be\u03b7 \u03ba\u03b1\u03b9 \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03b5\u03bd\u03cc\u03c2 \u03a3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 \u0394\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u03a0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\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. \u0391\u03bd\u03b1\u03bb\u03c5\u03c4\u03b9\u03ba\u03cc\u03c4\u03b5\u03c1\u03b1, \u03c4\u03bf \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf \u03b2\u03b1\u03c3\u03af\u03b6\u03b5\u03c4\u03b1\u03b9 \u03c3\u03c4\u03b7\u03bd \u03c0\u03c1\u03bf\u03c3\u03ad\u03b3\u03b3\u03b9\u03c3\u03b7 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u03ba\u03b9\u03bd\u03b4\u03cd\u03bd\u03bf\u03c5 \u03ba\u03b1\u03b9 \u03b5\u03c3\u03c4\u03b9\u03ac\u03b6\u03b5\u03b9:<\/p>\r\n<ul>\r\n<li>\u03c3\u03c4\u03b7 \u03b4\u03b9\u03b1\u03c3\u03c6\u03ac\u03bb\u03b9\u03c3\u03b7 \u03c4\u03b7\u03c2 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03ba\u03b1\u03b9 \u03b1\u03c3\u03c6\u03ac\u03bb\u03b5\u03b9\u03b1\u03c2 \u03c4\u03c9\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd,<\/li>\r\n<li>\u03c3\u03c4\u03b7\u03bd \u03b9\u03c7\u03bd\u03b7\u03bb\u03b1\u03c3\u03b9\u03bc\u03cc\u03c4\u03b7\u03c4\u03b1,<\/li>\r\n<li>\u03c3\u03c4\u03bf\u03bd \u03ad\u03bb\u03b5\u03b3\u03c7\u03bf \u03c4\u03c9\u03bd \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03b9\u03ce\u03bd,<\/li>\r\n<li>\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,<\/li>\r\n<li>\u03c3\u03c4\u03b7 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u03bc\u03b7 \u03c3\u03c5\u03bc\u03bc\u03bf\u03c1\u03c6\u03ce\u03c3\u03b5\u03c9\u03bd \u03ba\u03b1\u03b9 \u03b1\u03bd\u03b1\u03ba\u03bb\u03ae\u03c3\u03b5\u03c9\u03bd,<\/li>\r\n<li>\u03c3\u03c4\u03b7 \u03c3\u03c5\u03bd\u03b5\u03c7\u03ae \u03c0\u03b1\u03c1\u03b1\u03ba\u03bf\u03bb\u03bf\u03cd\u03b8\u03b7\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03b2\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7.<\/li>\r\n<\/ul>\r\n<p>\u03a4\u03bf \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf ISO \u03b3\u03b9\u03b1 \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 \u03b5\u03af\u03bd\u03b1\u03b9 \u03c0\u03bb\u03ae\u03c1\u03c9\u03c2 \u03b5\u03c5\u03b8\u03c5\u03b3\u03c1\u03b1\u03bc\u03bc\u03b9\u03c3\u03bc\u03ad\u03bd\u03bf \u03bc\u03b5 \u03c4\u03b9\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03c9\u03bd \u0395\u03c5\u03c1\u03c9\u03c0\u03b1\u03ca\u03ba\u03ce\u03bd \u039a\u03b1\u03bd\u03bf\u03bd\u03b9\u03c3\u03bc\u03cc\u03c2 MDR 2010\/745 \u03ba\u03b1\u03b9 IVDR 2017\/746.<\/p>\r\n<h2><strong>\u03a0\u03bf\u03b9\u03b5\u03c2 \u0395\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 <\/strong><strong>\u0391\u03c6\u03bf\u03c1\u03ac<\/strong><\/h2>\r\n<p>\u0397 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 ISO 13485 \u03b1\u03c6\u03bf\u03c1\u03ac \u03b5\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\u03b5 \u03bf\u03c0\u03bf\u03b9\u03bf\u03b4\u03ae\u03c0\u03bf\u03c4\u03b5 \u03c3\u03c4\u03ac\u03b4\u03b9\u03bf \u03c4\u03bf\u03c5 \u03ba\u03cd\u03ba\u03bb\u03bf\u03c5 \u03b6\u03c9\u03ae\u03c2 \u03b5\u03bd\u03cc\u03c2 \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03bf\u03cd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03bf\u03c2.<\/p>\r\n<p>\u0395\u03bd\u03b4\u03b5\u03b9\u03ba\u03c4\u03b9\u03ba\u03ac \u03b1\u03c6\u03bf\u03c1\u03ac:<\/p>\r\n<ul>\r\n<li>\u039a\u03b1\u03c4\u03b1\u03c3\u03ba\u03b5\u03c5\u03b1\u03c3\u03c4\u03ad\u03c2 \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>\r\n<li>\u0395\u03b9\u03c3\u03b1\u03b3\u03c9\u03b3\u03b5\u03af\u03c2 \u03ba\u03b1\u03b9 \u03b4\u03b9\u03b1\u03bd\u03bf\u03bc\u03b5\u03af\u03c2,<\/li>\r\n<li>\u0395\u03c4\u03b1\u03b9\u03c1\u03b5\u03af\u03b5\u03c2 \u03b1\u03c0\u03bf\u03b8\u03ae\u03ba\u03b5\u03c5\u03c3\u03b7\u03c2 \u03ba\u03b1\u03b9 logistics,<\/li>\r\n<li>\u0395\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03b5\u03c7\u03bd\u03b9\u03ba\u03ae\u03c2 \u03c5\u03c0\u03bf\u03c3\u03c4\u03ae\u03c1\u03b9\u03be\u03b7\u03c2 \u03ba\u03b1\u03b9 \u03c3\u03c5\u03bd\u03c4\u03ae\u03c1\u03b7\u03c3\u03b7\u03c2,<\/li>\r\n<li>\u0395\u03c4\u03b1\u03b9\u03c1\u03b5\u03af\u03b5\u03c2 \u03b1\u03c0\u03bf\u03c3\u03c4\u03b5\u03af\u03c1\u03c9\u03c3\u03b7\u03c2 \u03ba\u03b1\u03b9 \u03c3\u03c5\u03c3\u03ba\u03b5\u03c5\u03b1\u03c3\u03af\u03b1\u03c2,<\/li>\r\n<li>\u0395\u03c4\u03b1\u03b9\u03c1\u03b5\u03af\u03b5\u03c2 in vitro \u03b4\u03b9\u03b1\u03b3\u03bd\u03c9\u03c3\u03c4\u03b9\u03ba\u03ce\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd (IVD),<\/li>\r\n<li>\u03a0\u03b1\u03c1\u03cc\u03c7\u03bf\u03c5\u03c2 \u03c5\u03c0\u03b7\u03c1\u03b5\u03c3\u03b9\u03ce\u03bd \u03c3\u03c7\u03b5\u03c4\u03b9\u03ba\u03ce\u03bd \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.<\/li>\r\n<\/ul>\r\n<h2><strong>\u03a4\u03b1 \u0392\u03b1\u03c3\u03b9\u03ba\u03ac \u039f\u03c6\u03ad\u03bb\u03b7 \u03b5\u03bd\u03cc\u03c2 \u03a3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 \u03a0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u0399\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd \u03a0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd<\/strong><\/h2>\r\n<ol>\r\n<li><strong> \u03a3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03bc\u03b5 \u03c4\u03b7 \u03bd\u03bf\u03bc\u03bf\u03b8\u03b5\u03c3\u03af\u03b1: <\/strong>\u03a4\u03bf \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf \u03b1\u03c5\u03c4\u03cc \u03b2\u03bf\u03b7\u03b8\u03ac \u03c4\u03b9\u03c2 \u03b5\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\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 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03b7\u03c2 \u03b5\u03c5\u03c1\u03c9\u03c0\u03b1\u03ca\u03ba\u03ae\u03c2 (MDR \u03ba\u03b1\u03b9 IVDR) \u03ba\u03b1\u03b9 \u03b5\u03b8\u03bd\u03b9\u03ba\u03ae\u03c2 \u03bd\u03bf\u03bc\u03bf\u03b8\u03b5\u03c3\u03af\u03b1\u03c2 \u03b3\u03b9\u03b1 \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 (\u03a5\u03c0\u03bf\u03c5\u03c1\u03b3\u03b9\u03ba\u03ae \u0391\u03c0\u03cc\u03c6\u03b1\u03c3\u03b7 \u03943(\u03b1)4822\/2025).<\/li>\r\n<li><strong> \u0392\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7 \u03b1\u03be\u03b9\u03bf\u03c0\u03b9\u03c3\u03c4\u03af\u03b1\u03c2 \u03ba\u03b1\u03b9 \u03b5\u03c4\u03b1\u03b9\u03c1\u03b9\u03ba\u03ae\u03c2 \u03b5\u03b9\u03ba\u03cc\u03bd\u03b1\u03c2: <\/strong>\u0397 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03b1\u03c0\u03bf\u03b4\u03b5\u03b9\u03ba\u03bd\u03cd\u03b5\u03b9 \u03cc\u03c4\u03b9 \u03b7 \u03b5\u03c0\u03b9\u03c7\u03b5\u03af\u03c1\u03b7\u03c3\u03b7 \u03bb\u03b5\u03b9\u03c4\u03bf\u03c5\u03c1\u03b3\u03b5\u03af \u03bc\u03b5 \u03bf\u03c1\u03b3\u03b1\u03bd\u03c9\u03bc\u03ad\u03bd\u03b5\u03c2 \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b5\u03c2 \u03ba\u03b1\u03b9 \u03c5\u03c8\u03b7\u03bb\u03ac \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03b1 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2.<\/li>\r\n<li><strong> \u0395\u03bd\u03af\u03c3\u03c7\u03c5\u03c3\u03b7 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03b9\u03ce\u03bd \u03ba\u03b1\u03b9 \u03c3\u03c5\u03bc\u03bc\u03b5\u03c4\u03bf\u03c7\u03ae\u03c2 \u03c3\u03b5 \u03b4\u03b9\u03b1\u03b3\u03c9\u03bd\u03b9\u03c3\u03bc\u03bf\u03cd\u03c2: <\/strong>\u03a0\u03bf\u03bb\u03bb\u03bf\u03af \u03b4\u03b7\u03bc\u03cc\u03c3\u03b9\u03bf\u03b9 \u03ba\u03b1\u03b9 \u03b9\u03b4\u03b9\u03c9\u03c4\u03b9\u03ba\u03bf\u03af \u03bf\u03c1\u03b3\u03b1\u03bd\u03b9\u03c3\u03bc\u03bf\u03af \u03b1\u03c0\u03b1\u03b9\u03c4\u03bf\u03cd\u03bd \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03b9\u03b7\u03bc\u03ad\u03bd\u03bf \u03c3\u03cd\u03c3\u03c4\u03b7\u03bc\u03b1 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03b3\u03b9\u03b1 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b1.<\/li>\r\n<li><strong> \u039c\u03b5\u03af\u03c9\u03c3\u03b7 \u03bb\u03b5\u03b9\u03c4\u03bf\u03c5\u03c1\u03b3\u03b9\u03ba\u03ce\u03bd \u03ba\u03b9\u03bd\u03b4\u03cd\u03bd\u03c9\u03bd: <\/strong>\u0397 \u03c3\u03c5\u03c3\u03c4\u03b7\u03bc\u03b1\u03c4\u03b9\u03ba\u03ae \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u03ba\u03b9\u03bd\u03b4\u03cd\u03bd\u03c9\u03bd \u03c0\u03b5\u03c1\u03b9\u03bf\u03c1\u03af\u03b6\u03b5\u03b9 \u03c3\u03c6\u03ac\u03bb\u03bc\u03b1\u03c4\u03b1, \u03b1\u03c0\u03bf\u03ba\u03bb\u03af\u03c3\u03b5\u03b9\u03c2 \u03ba\u03b1\u03b9 \u03c0\u03c1\u03bf\u03b2\u03bb\u03ae\u03bc\u03b1\u03c4\u03b1 \u03c3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7\u03c2.<\/li>\r\n<li><strong> \u0392\u03b5\u03bb\u03c4\u03b9\u03c9\u03bc\u03ad\u03bd\u03b7 \u03b9\u03c7\u03bd\u03b7\u03bb\u03b1\u03c3\u03b9\u03bc\u03cc\u03c4\u03b7\u03c4\u03b1: <\/strong>\u03a4\u03bf \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf \u03b1\u03c0\u03b1\u03b9\u03c4\u03b5\u03af \u03c0\u03bb\u03ae\u03c1\u03b7 \u03ba\u03b1\u03c4\u03b1\u03b3\u03c1\u03b1\u03c6\u03ae \u03ba\u03b1\u03b9 \u03ad\u03bb\u03b5\u03b3\u03c7\u03bf \u03c4\u03c9\u03bd \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03b9\u03ce\u03bd, \u03b4\u03b9\u03b5\u03c5\u03ba\u03bf\u03bb\u03cd\u03bd\u03bf\u03bd\u03c4\u03b1\u03c2 \u03b1\u03bd\u03b1\u03ba\u03bb\u03ae\u03c3\u03b5\u03b9\u03c2 \u03ba\u03b1\u03b9 \u03b5\u03bb\u03ad\u03b3\u03c7\u03bf\u03c5\u03c2.<\/li>\r\n<li><strong> \u0395\u03c5\u03ba\u03bf\u03bb\u03cc\u03c4\u03b5\u03c1\u03b7 \u03c0\u03c1\u03cc\u03c3\u03b2\u03b1\u03c3\u03b7 \u03c3\u03b5 \u03b4\u03b9\u03b5\u03b8\u03bd\u03b5\u03af\u03c2 \u03b1\u03b3\u03bf\u03c1\u03ad\u03c2: <\/strong>\u0397 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 ISO 13485 \u03b1\u03bd\u03b1\u03b3\u03bd\u03c9\u03c1\u03af\u03b6\u03b5\u03c4\u03b1\u03b9 \u03c0\u03b1\u03b3\u03ba\u03bf\u03c3\u03bc\u03af\u03c9\u03c2 \u03ba\u03b1\u03b9 \u03b5\u03bd\u03b9\u03c3\u03c7\u03cd\u03b5\u03b9 \u03c4\u03b7\u03bd \u03b5\u03be\u03b1\u03b3\u03c9\u03b3\u03b9\u03ba\u03ae \u03b4\u03c1\u03b1\u03c3\u03c4\u03b7\u03c1\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1.<\/li>\r\n<\/ol>\r\n<h2><strong>ISO 13485 \u03ba\u03b1\u03b9 \u03a5\u0391 \u03943(\u03b1)4822\/2025<\/strong><\/h2>\r\n<p>\u0397 \u03bd\u03ad\u03b1 \u03a5\u03c0\u03bf\u03c5\u03c1\u03b3\u03b9\u03ba\u03ae \u0391\u03c0\u03cc\u03c6\u03b1\u03c3\u03b7 \u03943(\u03b1)4822\/2025, \u03b7 \u03bf\u03c0\u03bf\u03af\u03b1 \u03b4\u03b7\u03bc\u03bf\u03c3\u03b9\u03b5\u03cd\u03b8\u03b7\u03ba\u03b5 \u03c3\u03c4\u03bf \u03a6\u0395\u039a 1197\/\u0392\/2025, \u03c4\u03c1\u03bf\u03c0\u03bf\u03c0\u03bf\u03b9\u03b5\u03af \u03ba\u03b1\u03b9 \u03ba\u03c9\u03b4\u03b9\u03ba\u03bf\u03c0\u03bf\u03b9\u03b5\u03af \u03c4\u03b7\u03bd \u03c0\u03c1\u03bf\u03b7\u03b3\u03bf\u03cd\u03bc\u03b5\u03bd\u03b7 \u03a5\u0391 1348\/2004 \u03c3\u03c7\u03b5\u03c4\u03b9\u03ba\u03ac \u03bc\u03b5 \u03c4\u03b9\u03c2 \u03b1\u03c1\u03c7\u03ad\u03c2 \u03ba\u03b1\u03b9 \u03ba\u03b1\u03c4\u03b5\u03c5\u03b8\u03c5\u03bd\u03c4\u03ae\u03c1\u03b9\u03b5\u03c2 \u03b3\u03c1\u03b1\u03bc\u03bc\u03ad\u03c2 \u03bf\u03c1\u03b8\u03ae\u03c2 \u03c0\u03c1\u03b1\u03ba\u03c4\u03b9\u03ba\u03ae\u03c2 \u03b4\u03b9\u03b1\u03bd\u03bf\u03bc\u03ae\u03c2 \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 \u03c3\u03c4\u03b7\u03bd \u0395\u03bb\u03bb\u03ac\u03b4\u03b1.<\/p>\r\n<p>\u0395\u03bd\u03b4\u03b9\u03b1\u03c6\u03ad\u03c1\u03bf\u03bd \u03c0\u03b1\u03c1\u03bf\u03c5\u03c3\u03b9\u03ac\u03b6\u03b5\u03b9 \u03b7 \u03c0\u03b1\u03c1\u03ac\u03b3\u03c1\u03b1\u03c6\u03bf\u03c2 2 \u03c4\u03bf\u03c5 \u03ac\u03c1\u03b8\u03c1\u03bf\u03c5 2 \u03c4\u03b7\u03c2 \u03a5\u0391, \u03c3\u03cd\u03bc\u03c6\u03c9\u03bd\u03b1 \u03bc\u03b5 \u03c4\u03b7\u03bd \u03bf\u03c0\u03bf\u03af\u03b1:<\/p>\r\n<p>\u00ab\u039f<em>\u03b9 \u03bf\u03c1\u03b3\u03b1\u03bd\u03b9\u03c3\u03bc\u03bf\u03af \u03c4\u03b7\u03c2 \u03c0\u03b1\u03c1. 1 \u03c4\u03bf\u03c5 \u03c0\u03b1\u03c1\u03cc\u03bd\u03c4\u03bf\u03c2 \u03ac\u03c1\u03b8\u03c1\u03bf\u03c5, \u03ba\u03b1\u03c4\u03ac \u03ac\u03c3\u03ba\u03b7\u03c3\u03b7 \u03c4\u03b7\u03c2 \u03c0\u03b5\u03c1\u03b9\u03b3\u03c1\u03b1\u03c6\u03cc\u03bc\u03b5\u03bd\u03b7\u03c2 \u03c3\u03c4\u03bf \u03ac\u03c1\u03b8\u03c1\u03bf \u03b1\u03c5\u03c4\u03cc \u03b4\u03c1\u03b1\u03c3\u03c4\u03b7\u03c1\u03b9\u03cc\u03c4\u03b7\u03c4\u03ac\u03c2 \u03c4\u03bf\u03c5\u03c2, \u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03bf\u03c5\u03bd \u03c5\u03c0\u03cc\u03c8\u03b7 \u03c4\u03bf\u03c5\u03c2 \u03c4\u03b7\u03bd \u03cd\u03c0\u03b1\u03c1\u03be\u03b7 \u03a3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03a0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1 \u03ba\u03b1\u03c4\u03ac \u03c4\u03b1 \u03b9\u03c3\u03c7\u03cd\u03bf\u03bd\u03c4\u03b1 \u03c3\u03c7\u03b5\u03c4\u03b9\u03ba\u03ac \u03b4\u03b9\u03b5\u03b8\u03bd\u03ae (<\/em><em>ISO) \u03ae\/\u03ba\u03b1\u03b9 \u03b5\u03c5\u03c1\u03c9\u03c0\u03b1\u03ca\u03ba\u03ac (<\/em><em>EN) \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03b1.<\/em>\u00bb<\/p>\r\n<p>\u0397 \u03a5\u0391 4822\/2025 \u03b1\u03c6\u03bf\u03c1\u03ac \u03b5\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\u03b7\u03bd \u03b5\u03b9\u03c3\u03b1\u03b3\u03c9\u03b3\u03ae, \u03b5\u03be\u03b1\u03b3\u03c9\u03b3\u03ae, \u03b5\u03bd\u03b4\u03bf\u03ba\u03bf\u03b9\u03bd\u03bf\u03c4\u03b9\u03ba\u03ae \u03b4\u03b9\u03b1\u03ba\u03af\u03bd\u03b7\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03b4\u03b9\u03b1\u03bd\u03bf\u03bc\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. (\u03ac\u03c1\u03b8\u03c1\u03bf 1, \u03c0\u03b1\u03c1.2).<\/p>\r\n<p>\u03a4\u03bf \u03bd\u03ad\u03bf \u03c0\u03bb\u03b1\u03af\u03c3\u03b9\u03bf \u03b4\u03af\u03bd\u03b5\u03b9 \u03b9\u03b4\u03b9\u03b1\u03af\u03c4\u03b5\u03c1\u03b7 \u03ad\u03bc\u03c6\u03b1\u03c3\u03b7:<\/p>\r\n<ul>\r\n<li>\u03c3\u03c4\u03b7\u03bd \u03b9\u03c7\u03bd\u03b7\u03bb\u03b1\u03c3\u03b9\u03bc\u03cc\u03c4\u03b7\u03c4\u03b1,<\/li>\r\n<li>\u03c3\u03c4\u03b9\u03c2 \u03c3\u03c5\u03bd\u03b8\u03ae\u03ba\u03b5\u03c2 \u03b1\u03c0\u03bf\u03b8\u03ae\u03ba\u03b5\u03c5\u03c3\u03b7\u03c2 \u03ba\u03b1\u03b9 \u03bc\u03b5\u03c4\u03b1\u03c6\u03bf\u03c1\u03ac\u03c2,<\/li>\r\n<li>\u03c3\u03c4\u03b7\u03bd \u03b5\u03ba\u03c0\u03b1\u03af\u03b4\u03b5\u03c5\u03c3\u03b7 \u03c0\u03c1\u03bf\u03c3\u03c9\u03c0\u03b9\u03ba\u03bf\u03cd,<\/li>\r\n<li>\u03c3\u03c4\u03b7 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u03ba\u03b9\u03bd\u03b4\u03cd\u03bd\u03bf\u03c5,<\/li>\r\n<li>\u03c3\u03c4\u03b7 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7 \u03bc\u03b7 \u03c3\u03c5\u03bc\u03bc\u03bf\u03c1\u03c6\u03bf\u03cd\u03bc\u03b5\u03bd\u03c9\u03bd \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03c9\u03bd,<\/li>\r\n<li>\u03c3\u03c4\u03b9\u03c2 \u03b4\u03b9\u03bf\u03c1\u03b8\u03c9\u03c4\u03b9\u03ba\u03ad\u03c2 \u03ba\u03b1\u03b9 \u03c0\u03c1\u03bf\u03bb\u03b7\u03c0\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b5\u03bd\u03ad\u03c1\u03b3\u03b5\u03b9\u03b5\u03c2,<\/li>\r\n<li>\u03c3\u03c4\u03b7 \u03b4\u03b9\u03b1\u03c4\u03ae\u03c1\u03b7\u03c3\u03b7 \u03c4\u03b5\u03ba\u03bc\u03b7\u03c1\u03af\u03c9\u03c3\u03b7\u03c2 \u03ba\u03b1\u03b9 \u03b1\u03c1\u03c7\u03b5\u03af\u03c9\u03bd.<\/li>\r\n<\/ul>\r\n<p>\u03a3\u03c4\u03b7\u03bd \u03c0\u03c1\u03ac\u03be\u03b7, \u03c0\u03bf\u03bb\u03bb\u03ad\u03c2 \u03b1\u03c0\u03cc \u03c4\u03b9\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03b7\u03c2 \u03a5\u0391 4822\/2025 \u03ba\u03b1\u03bb\u03cd\u03c0\u03c4\u03bf\u03bd\u03c4\u03b1\u03b9 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03c3\u03bc\u03b1\u03c4\u03b9\u03ba\u03ac \u03bc\u03ad\u03c3\u03b1 \u03b1\u03c0\u03cc \u03c4\u03b7\u03bd \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03b5\u03bd\u03cc\u03c2 \u03bf\u03bb\u03bf\u03ba\u03bb\u03b7\u03c1\u03c9\u03bc\u03ad\u03bd\u03bf\u03c5 \u03c3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 ISO 13485.<\/p>\r\n<h2><strong>\u0393\u03b9\u03b1\u03c4\u03af \u0391\u03c5\u03be\u03ac\u03bd\u03b5\u03c4\u03b1\u03b9 \u03b7 \u0391\u03bd\u03ac\u03b3\u03ba\u03b7 \u03b3\u03b9\u03b1 ISO 13485 \u03c4\u03bf 2026<\/strong><\/h2>\r\n<p>\u039f\u03b9 \u03b1\u03c5\u03be\u03b7\u03bc\u03ad\u03bd\u03b5\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7\u03c2 \u03c0\u03bf\u03c5 \u03c0\u03c1\u03bf\u03ba\u03cd\u03c0\u03c4\u03bf\u03c5\u03bd \u03b1\u03c0\u03cc \u03c4\u03bf\u03c5\u03c2 \u039a\u03b1\u03bd\u03bf\u03bd\u03b9\u03c3\u03bc\u03bf\u03cd\u03c2 MDR \u03ba\u03b1\u03b9 IVDR, \u03c3\u03b5 \u03c3\u03c5\u03bd\u03b4\u03c5\u03b1\u03c3\u03bc\u03cc \u03bc\u03b5 \u03c4\u03b7\u03bd \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03c4\u03b7\u03c2 \u03a5\u0391 \u03943(\u03b1)4822\/2025, \u03bf\u03b4\u03b7\u03b3\u03bf\u03cd\u03bd \u03bf\u03bb\u03bf\u03ad\u03bd\u03b1 \u03ba\u03b1\u03b9 \u03c0\u03b5\u03c1\u03b9\u03c3\u03c3\u03cc\u03c4\u03b5\u03c1\u03b5\u03c2 \u03b5\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c3\u03c4\u03b7\u03bd \u03c5\u03b9\u03bf\u03b8\u03ad\u03c4\u03b7\u03c3\u03b7 \u03bf\u03c1\u03b3\u03b1\u03bd\u03c9\u03bc\u03ad\u03bd\u03c9\u03bd \u03c3\u03c5\u03c3\u03c4\u03b7\u03bc\u03ac\u03c4\u03c9\u03bd \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2.<\/p>\r\n<p>\u03a0\u03b1\u03c1\u03ac\u03bb\u03bb\u03b7\u03bb\u03b1, \u03c4\u03cc\u03c3\u03bf \u03b4\u03b7\u03bc\u03cc\u03c3\u03b9\u03bf\u03b9 \u03c6\u03bf\u03c1\u03b5\u03af\u03c2 \u03cc\u03c3\u03bf \u03ba\u03b1\u03b9 \u03b4\u03b9\u03b5\u03b8\u03bd\u03b5\u03af\u03c2 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03ac\u03c4\u03b5\u03c2 \u03b6\u03b7\u03c4\u03bf\u03cd\u03bd \u03c4\u03b5\u03ba\u03bc\u03b7\u03c1\u03b9\u03c9\u03bc\u03ad\u03bd\u03b5\u03c2 \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b5\u03c2 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03ba\u03b1\u03b9 \u03b1\u03c0\u03bf\u03b4\u03b5\u03b4\u03b5\u03b9\u03b3\u03bc\u03ad\u03bd\u03b7 \u03c3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03bc\u03b5 \u03c4\u03b1 \u03b9\u03c3\u03c7\u03cd\u03bf\u03bd\u03c4\u03b1 \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03b1 \u03b3\u03b9\u03b1 medical devices.<\/p>\r\n<p>\u0397 \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03b5\u03bd\u03cc\u03c2 \u03c3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 ISO 13485 \u03b2\u03bf\u03b7\u03b8\u03ac \u03c4\u03b9\u03c2 \u03b5\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \u03bd\u03b1 \u03b1\u03bd\u03c4\u03b1\u03c0\u03bf\u03ba\u03c1\u03af\u03bd\u03bf\u03bd\u03c4\u03b1\u03b9 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03c3\u03bc\u03b1\u03c4\u03b9\u03ba\u03ac \u03c3\u03b5 \u03b1\u03c5\u03c4\u03ad\u03c2 \u03c4\u03b9\u03c2 \u03c3\u03cd\u03b3\u03c7\u03c1\u03bf\u03bd\u03b5\u03c2 \u03ba\u03b1\u03bd\u03bf\u03bd\u03b9\u03c3\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2.<\/p>\r\n<h2><strong>\u03a0\u03bf\u03b9\u03b1 \u0395\u03af\u03bd\u03b1\u03b9 \u03c4\u03b1 \u0392\u03b1\u03c3\u03b9\u03ba\u03ac <\/strong><strong>\u0392\u03ae\u03bc\u03b1\u03c4\u03b1 \u03b3\u03b9\u03b1 \u03a0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 ISO 13485<\/strong><\/h2>\r\n<h3><strong>#1 \u0391\u03c1\u03c7\u03b9\u03ba\u03ae \u03b1\u03be\u03b9\u03bf\u03bb\u03cc\u03b3\u03b7\u03c3\u03b7 (<\/strong><strong>Gap Analysis)<\/strong><\/h3>\r\n<p>\u039a\u03b1\u03c4\u03b1\u03b3\u03c1\u03ac\u03c6\u03bf\u03bd\u03c4\u03b1\u03b9 \u03bf\u03b9 \u03c5\u03c6\u03b9\u03c3\u03c4\u03ac\u03bc\u03b5\u03bd\u03b5\u03c2 \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b5\u03c2 \u03ba\u03b1\u03b9 \u03b5\u03bd\u03c4\u03bf\u03c0\u03af\u03b6\u03bf\u03bd\u03c4\u03b1\u03b9 \u03c4\u03b1 \u03c3\u03b7\u03bc\u03b5\u03af\u03b1 \u03c0\u03bf\u03c5 \u03c7\u03c1\u03b5\u03b9\u03ac\u03b6\u03bf\u03bd\u03c4\u03b1\u03b9 \u03b2\u03b5\u03bb\u03c4\u03af\u03c9\u03c3\u03b7.<\/p>\r\n<h3><strong>#2 \u0391\u03bd\u03ac\u03c0\u03c4\u03c5\u03be\u03b7 \u03c3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2<\/strong><\/h3>\r\n<p>\u03a4\u03bf \u03c3\u03c4\u03ac\u03b4\u03b9\u03bf \u03b1\u03c5\u03c4\u03cc \u03c0\u03b5\u03c1\u03b9\u03bb\u03b1\u03bc\u03b2\u03ac\u03bd\u03b5\u03b9 \u03c4\u03b7 \u03b4\u03b7\u03bc\u03b9\u03bf\u03c5\u03c1\u03b3\u03af\u03b1 \u03c4\u03c9\u03bd \u03b1\u03c0\u03b1\u03c1\u03b1\u03af\u03c4\u03b7\u03c4\u03c9\u03bd \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03b9\u03ce\u03bd, \u03b5\u03bd\u03c4\u03cd\u03c0\u03c9\u03bd \u03ba\u03b1\u03b9 \u03c0\u03bf\u03bb\u03b9\u03c4\u03b9\u03ba\u03ce\u03bd.<\/p>\r\n<h3><strong>#3 \u0395\u03ba\u03c0\u03b1\u03af\u03b4\u03b5\u03c5\u03c3\u03b7 \u03c0\u03c1\u03bf\u03c3\u03c9\u03c0\u03b9\u03ba\u03bf\u03cd<\/strong><\/h3>\r\n<p>\u03a4\u03bf \u03c0\u03c1\u03bf\u03c3\u03c9\u03c0\u03b9\u03ba\u03cc \u03b5\u03ba\u03c0\u03b1\u03b9\u03b4\u03b5\u03cd\u03b5\u03c4\u03b1\u03b9 \u03c3\u03c4\u03b9\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03bf\u03c5 \u03c0\u03c1\u03bf\u03c4\u03cd\u03c0\u03bf\u03c5 \u03ba\u03b1\u03b9 \u03c3\u03c4\u03b9\u03c2 \u03bd\u03ad\u03b5\u03c2 \u03b4\u03b9\u03b1\u03b4\u03b9\u03ba\u03b1\u03c3\u03af\u03b5\u03c2.<\/p>\r\n<h3><strong>#4 \u0395\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03c3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2<\/strong><\/h3>\r\n<p>\u0397 \u03b5\u03c0\u03b9\u03c7\u03b5\u03af\u03c1\u03b7\u03c3\u03b7 \u03b5\u03c6\u03b1\u03c1\u03bc\u03cc\u03b6\u03b5\u03b9 \u03c0\u03c1\u03b1\u03ba\u03c4\u03b9\u03ba\u03ac \u03c4\u03bf \u03c3\u03cd\u03c3\u03c4\u03b7\u03bc\u03b1 \u03c3\u03c4\u03b7\u03bd \u03ba\u03b1\u03b8\u03b7\u03bc\u03b5\u03c1\u03b9\u03bd\u03ae \u03bb\u03b5\u03b9\u03c4\u03bf\u03c5\u03c1\u03b3\u03af\u03b1 \u03c4\u03b7\u03c2.<\/p>\r\n<h3><strong>#5 \u0395\u03c3\u03c9\u03c4\u03b5\u03c1\u03b9\u03ba\u03ae \u03b5\u03c0\u03b9\u03b8\u03b5\u03ce\u03c1\u03b7\u03c3\u03b7<\/strong><\/h3>\r\n<p>\u03a4\u03bf \u03b5\u03c0\u03cc\u03bc\u03b5\u03bd\u03bf \u03c3\u03c4\u03ac\u03b4\u03b9\u03bf \u03b5\u03af\u03bd\u03b1\u03b9 \u03ad\u03bd\u03b1\u03c2 \u03b5\u03c3\u03c9\u03c4\u03b5\u03c1\u03b9\u03ba\u03cc\u03c2 \u03ad\u03bb\u03b5\u03b3\u03c7\u03bf\u03c2 \u03b3\u03b9\u03b1 \u03c4\u03b7\u03bd \u03b1\u03be\u03b9\u03bf\u03bb\u03cc\u03b3\u03b7\u03c3\u03b7 \u03c4\u03b7\u03c2 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03c3\u03bc\u03b1\u03c4\u03b9\u03ba\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03c4\u03bf\u03c5 \u03c3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2.<\/p>\r\n<h3><strong>#6 \u03a0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03b1\u03c0\u03cc \u03b4\u03b9\u03b1\u03c0\u03b9\u03c3\u03c4\u03b5\u03c5\u03bc\u03ad\u03bd\u03bf \u03c6\u03bf\u03c1\u03ad\u03b1<\/strong><\/h3>\r\n<p>\u039f \u03c6\u03bf\u03c1\u03ad\u03b1\u03c2 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7\u03c2 \u03b4\u03b9\u03b5\u03bd\u03b5\u03c1\u03b3\u03b5\u03af \u03b5\u03c0\u03b9\u03b8\u03b5\u03ce\u03c1\u03b7\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03b5\u03ba\u03b4\u03af\u03b4\u03b5\u03b9 \u03c4\u03bf \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03b9\u03b7\u03c4\u03b9\u03ba\u03cc ISO 13485.<\/p>\r\n<h2><strong>\u0395\u03bd \u039a\u03b1\u03c4\u03b1\u03ba\u03bb\u03b5\u03af\u03b4\u03b9<\/strong><\/h2>\r\n<p>\u03a4\u03bf ISO 13485 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03af \u03c0\u03bb\u03ad\u03bf\u03bd \u03b2\u03b1\u03c3\u03b9\u03ba\u03cc \u03b5\u03c1\u03b3\u03b1\u03bb\u03b5\u03af\u03bf \u03b3\u03b9\u03b1 \u03ba\u03ac\u03b8\u03b5 \u03b5\u03c0\u03b9\u03c7\u03b5\u03af\u03c1\u03b7\u03c3\u03b7 \u03c0\u03bf\u03c5 \u03b4\u03c1\u03b1\u03c3\u03c4\u03b7\u03c1\u03b9\u03bf\u03c0\u03bf\u03b9\u03b5\u03af\u03c4\u03b1\u03b9 \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. \u03a3\u03b5 \u03c3\u03c5\u03bd\u03b4\u03c5\u03b1\u03c3\u03bc\u03cc \u03bc\u03b5 \u03c4\u03b9\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03b7\u03c2 \u03a5\u0391 \u03943(\u03b1)4822\/2025, \u03c0\u03b1\u03c1\u03ad\u03c7\u03b5\u03b9 \u03c3\u03c4\u03b9\u03c2 \u03b5\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \u03b1\u03c5\u03be\u03b7\u03bc\u03ad\u03bd\u03b7 \u03c4\u03b5\u03ba\u03bc\u03b7\u03c1\u03af\u03c9\u03c3\u03b7, \u03b9\u03c7\u03bd\u03b7\u03bb\u03b1\u03c3\u03b9\u03bc\u03cc\u03c4\u03b7\u03c4\u03b1 \u03ba\u03b1\u03b9 \u03ad\u03bb\u03b5\u03b3\u03c7\u03bf \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2.<\/p>\r\n<p>\u0397 \u03ad\u03b3\u03ba\u03b1\u03b9\u03c1\u03b7 \u03c0\u03c1\u03bf\u03b5\u03c4\u03bf\u03b9\u03bc\u03b1\u03c3\u03af\u03b1 \u03ba\u03b1\u03b9 \u03b7 \u03c3\u03c9\u03c3\u03c4\u03ae \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03b5\u03bd\u03cc\u03c2 \u03c3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03c0\u03c1\u03bf\u03c3\u03c4\u03b1\u03c4\u03b5\u03cd\u03bf\u03c5\u03bd \u03c4\u03b7\u03bd \u03b5\u03c0\u03b9\u03c7\u03b5\u03af\u03c1\u03b7\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03b5\u03bd\u03b9\u03c3\u03c7\u03cd\u03bf\u03c5\u03bd \u03c4\u03b7\u03bd \u03b1\u03be\u03b9\u03bf\u03c0\u03b9\u03c3\u03c4\u03af\u03b1 \u03c4\u03b7\u03c2 \u03c3\u03c4\u03b7\u03bd \u03b5\u03bb\u03bb\u03b7\u03bd\u03b9\u03ba\u03ae \u03ba\u03b1\u03b9 \u03b4\u03b9\u03b5\u03b8\u03bd\u03ae \u03b1\u03b3\u03bf\u03c1\u03ac.<\/p>\r\n<p>\u0397 \u039d\u0395\u03a3\u03a4\u03a9\u03a1 \u03a3\u03a5\u039c\u0392\u039f\u03a5\u039b\u0395\u03a5\u03a4\u0399\u039a\u0397 \u0391.\u0395. \u03c5\u03c0\u03bf\u03c3\u03c4\u03b7\u03c1\u03af\u03b6\u03b5\u03b9 \u03b5\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03bf\u03c5 \u03ba\u03bb\u03ac\u03b4\u03bf\u03c5 \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 \u03c3\u03c4\u03b7\u03bd \u03b1\u03bd\u03ac\u03c0\u03c4\u03c5\u03be\u03b7 \u03ba\u03b1\u03b9 \u03b5\u03c6\u03b1\u03c1\u03bc\u03bf\u03b3\u03ae \u03c3\u03c5\u03c3\u03c4\u03b7\u03bc\u03ac\u03c4\u03c9\u03bd \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03c3\u03cd\u03bc\u03c6\u03c9\u03bd\u03b1 \u03bc\u03b5 \u03c4\u03bf ISO 13485 \u03ba\u03b1\u03b9 \u03c4\u03b9\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03b7\u03c2 \u03b5\u03bb\u03bb\u03b7\u03bd\u03b9\u03ba\u03ae\u03c2 \u03ba\u03b1\u03b9 \u03b5\u03c5\u03c1\u03c9\u03c0\u03b1\u03ca\u03ba\u03ae\u03c2 \u03bd\u03bf\u03bc\u03bf\u03b8\u03b5\u03c3\u03af\u03b1\u03c2.<\/p>\r\n<p>\u0395\u03c0\u03b9\u03ba\u03bf\u03b9\u03bd\u03c9\u03bd\u03ae\u03c3\u03c4\u03b5 \u03c3\u03ae\u03bc\u03b5\u03c1\u03b1 \u03b3\u03b9\u03b1 \u03bc\u03b9\u03b1 \u03b1\u03c1\u03c7\u03b9\u03ba\u03ae \u03c3\u03c5\u03bc\u03b2\u03bf\u03c5\u03bb\u03b5\u03c5\u03c4\u03b9\u03ba\u03ae \u03c3\u03c5\u03bd\u03ac\u03bd\u03c4\u03b7\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03b1\u03c0\u03bf\u03ba\u03c4\u03ae\u03c3\u03c4\u03b5 \u03ad\u03bd\u03b1 \u03c3\u03cd\u03c3\u03c4\u03b7\u03bc\u03b1 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03c0\u03c1\u03bf\u03c3\u03b1\u03c1\u03bc\u03bf\u03c3\u03bc\u03ad\u03bd\u03bf \u03c3\u03c4\u03b9\u03c2 \u03c0\u03c1\u03b1\u03b3\u03bc\u03b1\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b1\u03bd\u03ac\u03b3\u03ba\u03b5\u03c2 \u03c4\u03b7\u03c2 \u03b5\u03c0\u03b9\u03c7\u03b5\u03af\u03c1\u03b7\u03c3\u03ae\u03c2 \u03c3\u03b1\u03c2.<\/p>\r\n<p>\u03a3\u03c5\u03bc\u03c0\u03bb\u03b7\u03c1\u03ce\u03c3\u03c4\u03b5 <a href=\"https:\/\/www.nestor.com.gr\/en\/%CE%B5%CF%80%CE%B9%CE%BA%CE%BF%CE%B9%CE%BD%CF%89%CE%BD%CE%AF%CE%B1\/\" target=\"_blank\" rel=\"noopener\">\u03c4\u03b7 \u03c6\u03cc\u03c1\u03bc\u03b1 \u03b5\u03c0\u03b9\u03ba\u03bf\u03b9\u03bd\u03c9\u03bd\u03af\u03b1\u03c2<\/a> \u03b3\u03b9\u03b1 \u03bd\u03b1 \u03bc\u03ac\u03b8\u03b5\u03c4\u03b5 \u03c0\u03b5\u03c1\u03b9\u03c3\u03c3\u03cc\u03c4\u03b5\u03c1\u03b1.<\/p>\r\n<p>\u0394\u03b5\u03af\u03c4\u03b5 \u03c4\u03b7\u03bd <a href=\"http:\/\/www.nestor.com.gr\/wp-content\/uploads\/2026\/05\/20250201197.pdf\" target=\"_blank\" rel=\"noopener\">\u03a5\u0391 \u03943(\u03b1)4822\/2025<\/a>.<\/p>\r\n<p><strong>\u00a0<\/strong><\/p>\r\n<p><strong>\u00a0<\/strong><\/p>\r\n<h2><strong>FAQs \u03b3\u03b9\u03b1 \u03c4\u03bf ISO 13485 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03a5\u0391 4822\/2025<\/strong><\/h2>\r\n\r\n<div class=\"schema-faq wp-block-yoast-faq-block\">\r\n<div id=\"faq-question-1779268961617\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>\u0395\u03af\u03bd\u03b1\u03b9 \u03c5\u03c0\u03bf\u03c7\u03c1\u03b5\u03c9\u03c4\u03b9\u03ba\u03cc \u03c4\u03bf ISO 13485;<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">\u03a4\u03bf ISO 13485 \u03b4\u03b5\u03bd \u03b5\u03af\u03bd\u03b1\u03b9 \u03c0\u03ac\u03bd\u03c4\u03b1 \u03bd\u03bf\u03bc\u03b9\u03ba\u03ac \u03c5\u03c0\u03bf\u03c7\u03c1\u03b5\u03c9\u03c4\u03b9\u03ba\u03cc, \u03cc\u03bc\u03c9\u03c2 \u03c3\u03b5 \u03c0\u03bf\u03bb\u03bb\u03ad\u03c2 \u03c0\u03b5\u03c1\u03b9\u03c0\u03c4\u03ce\u03c3\u03b5\u03b9\u03c2 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03af \u03bf\u03c5\u03c3\u03b9\u03b1\u03c3\u03c4\u03b9\u03ba\u03ae \u03b1\u03c0\u03b1\u03af\u03c4\u03b7\u03c3\u03b7 \u03b3\u03b9\u03b1 \u03c3\u03c5\u03bd\u03b5\u03c1\u03b3\u03b1\u03c3\u03af\u03b5\u03c2, \u03b4\u03b9\u03b1\u03b3\u03c9\u03bd\u03b9\u03c3\u03bc\u03bf\u03cd\u03c2 \u03ba\u03b1\u03b9 \u03c3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7 \u03bc\u03b5 MDR\/IVDR.<\/p>\r\n<\/div>\r\n<div id=\"faq-question-1779268976954\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>\u03a0\u03cc\u03c3\u03bf \u03b4\u03b9\u03b1\u03c1\u03ba\u03b5\u03af \u03b7 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7;<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">\u0397 \u03b4\u03b9\u03ac\u03c1\u03ba\u03b5\u03b9\u03b1 \u03b5\u03be\u03b1\u03c1\u03c4\u03ac\u03c4\u03b1\u03b9 \u03b1\u03c0\u03cc \u03c4\u03bf \u03bc\u03ad\u03b3\u03b5\u03b8\u03bf\u03c2 \u03ba\u03b1\u03b9 \u03c4\u03b7\u03bd \u03b5\u03c4\u03bf\u03b9\u03bc\u03cc\u03c4\u03b7\u03c4\u03b1 \u03c4\u03b7\u03c2 \u03b5\u03c0\u03b9\u03c7\u03b5\u03af\u03c1\u03b7\u03c3\u03b7\u03c2. \u03a3\u03c5\u03bd\u03ae\u03b8\u03c9\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03bf\u03cd\u03bd\u03c4\u03b1\u03b9 \u03bc\u03b5\u03c1\u03b9\u03ba\u03bf\u03af \u03bc\u03ae\u03bd\u03b5\u03c2, \u03bc\u03b5\u03c4\u03b1\u03be\u03cd 6-12.<\/p>\r\n<\/div>\r\n<div id=\"faq-question-1779268986842\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>\u03a0\u03bf\u03b9\u03b5\u03c2 \u03b5\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \u03b1\u03c6\u03bf\u03c1\u03ac \u03b7 \u03a5\u0391 4822\/2025;<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">\u0391\u03c6\u03bf\u03c1\u03ac \u03b5\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c0\u03bf\u03c5 \u03b5\u03b9\u03c3\u03ac\u03b3\u03bf\u03c5\u03bd, \u03b1\u03c0\u03bf\u03b8\u03b7\u03ba\u03b5\u03cd\u03bf\u03c5\u03bd, \u03b4\u03b9\u03b1\u03bd\u03ad\u03bc\u03bf\u03c5\u03bd \u03ae \u03b5\u03be\u03ac\u03b3\u03bf\u03c5\u03bd \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ac \u03c0\u03c1\u03bf\u03ca\u03cc\u03bd\u03c4\u03b1 \u03c3\u03c4\u03b7\u03bd \u0395\u03bb\u03bb\u03ac\u03b4\u03b1.<\/p>\r\n<\/div>\r\n<div id=\"faq-question-1779269002420\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>\u03a3\u03c5\u03bd\u03b4\u03ad\u03b5\u03c4\u03b1\u03b9 \u03b7 \u03a5\u0391 4822\/2025 \u03bc\u03b5 \u03c4\u03bf ISO 13485;<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">\u039d\u03b1\u03b9. \u03a0\u03bf\u03bb\u03bb\u03ad\u03c2 \u03b1\u03c0\u03b1\u03b9\u03c4\u03ae\u03c3\u03b5\u03b9\u03c2 \u03c4\u03b7\u03c2 \u03a5\u0391 \u03ba\u03b1\u03bb\u03cd\u03c0\u03c4\u03bf\u03bd\u03c4\u03b1\u03b9 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03c3\u03bc\u03b1\u03c4\u03b9\u03ba\u03ac \u03bc\u03ad\u03c3\u03c9 \u03b5\u03bd\u03cc\u03c2 \u03bf\u03c1\u03b3\u03b1\u03bd\u03c9\u03bc\u03ad\u03bd\u03bf\u03c5 \u03c3\u03c5\u03c3\u03c4\u03ae\u03bc\u03b1\u03c4\u03bf\u03c2 ISO 13485.<\/p>\r\n<\/div>\r\n<div id=\"faq-question-1779269016275\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>\u03a7\u03c1\u03b5\u03b9\u03ac\u03b6\u03b5\u03c4\u03b1\u03b9 \u03b5\u03ba\u03c0\u03b1\u03af\u03b4\u03b5\u03c5\u03c3\u03b7 \u03c0\u03c1\u03bf\u03c3\u03c9\u03c0\u03b9\u03ba\u03bf\u03cd;<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">\u039d\u03b1\u03b9. \u03a4\u03cc\u03c3\u03bf \u03c4\u03bf ISO 13485 \u03cc\u03c3\u03bf \u03ba\u03b1\u03b9 \u03b7 \u03a5\u0391 4822\/2025 \u03b1\u03c0\u03b1\u03b9\u03c4\u03bf\u03cd\u03bd \u03c4\u03b5\u03ba\u03bc\u03b7\u03c1\u03b9\u03c9\u03bc\u03ad\u03bd\u03b7 \u03b5\u03ba\u03c0\u03b1\u03af\u03b4\u03b5\u03c5\u03c3\u03b7 \u03ba\u03b1\u03b9 \u03b1\u03be\u03b9\u03bf\u03bb\u03cc\u03b3\u03b7\u03c3\u03b7 \u03c0\u03c1\u03bf\u03c3\u03c9\u03c0\u03b9\u03ba\u03bf\u03cd.<\/p>\r\n<\/div>\r\n<div id=\"faq-question-1779269026448\" class=\"schema-faq-section\"><strong class=\"schema-faq-question\"><strong>\u039c\u03c0\u03bf\u03c1\u03b5\u03af \u03bc\u03b9\u03b1 \u03bc\u03b9\u03ba\u03c1\u03ae \u03b5\u03c0\u03b9\u03c7\u03b5\u03af\u03c1\u03b7\u03c3\u03b7 \u03bd\u03b1 \u03b5\u03c6\u03b1\u03c1\u03bc\u03cc\u03c3\u03b5\u03b9 ISO 13485;<\/strong><\/strong>\r\n<p class=\"schema-faq-answer\">\u03a6\u03c5\u03c3\u03b9\u03ba\u03ac. \u03a4\u03bf \u03c3\u03cd\u03c3\u03c4\u03b7\u03bc\u03b1 \u03bc\u03c0\u03bf\u03c1\u03b5\u03af \u03bd\u03b1 \u03c0\u03c1\u03bf\u03c3\u03b1\u03c1\u03bc\u03bf\u03c3\u03c4\u03b5\u03af \u03c3\u03c4\u03bf \u03bc\u03ad\u03b3\u03b5\u03b8\u03bf\u03c2 \u03ba\u03b1\u03b9 \u03c3\u03c4\u03b9\u03c2 \u03c0\u03c1\u03b1\u03b3\u03bc\u03b1\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b1\u03bd\u03ac\u03b3\u03ba\u03b5\u03c2 \u03ba\u03ac\u03b8\u03b5 \u03b5\u03c0\u03b9\u03c7\u03b5\u03af\u03c1\u03b7\u03c3\u03b7\u03c2.<\/p>\r\n<\/div>\r\n<\/div>\r\n\r\n\r\n<div class=\"wp-block-jetpack-contact-form is-layout-flex wp-container-jetpack-contact-form-is-layout-53c17e14 wp-block-jetpack-contact-form-is-layout-flex\"><a href=\"http:\/\/www.nestor.com.gr\/en\/blog\/iso-13485-iatrotexnologika-proionta\/\" target=\"_blank\" rel=\"noopener noreferrer\">Submit a form.<\/a><\/div>","protected":false},"excerpt":{"rendered":"<p>\u039f \u03ba\u03bb\u03ac\u03b4\u03bf\u03c2 \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 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03af \u03ad\u03bd\u03b1\u03bd \u03b1\u03c0\u03cc \u03c4\u03bf\u03c5\u03c2 \u03c0\u03bb\u03ad\u03bf\u03bd \u03b1\u03c5\u03c3\u03c4\u03b7\u03c1\u03ac \u03c1\u03c5\u03b8\u03bc\u03b9\u03b6\u03cc\u03bc\u03b5\u03bd\u03bf\u03c5\u03c2 \u03c4\u03bf\u03bc\u03b5\u03af\u03c2 \u03c3\u03c4\u03b7\u03bd \u0395\u03c5\u03c1\u03ce\u03c0\u03b7 \u03ba\u03b1\u03b9 \u03b4\u03b9\u03b5\u03b8\u03bd\u03ce\u03c2. \u039f\u03b9 \u03b5\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\u03b5 \u03b1\u03c5\u03c4\u03cc\u03bd \u03ba\u03b1\u03bb\u03bf\u03cd\u03bd\u03c4\u03b1\u03b9 \u03bd\u03b1 \u03b1\u03c0\u03bf\u03b4\u03b5\u03b9\u03ba\u03bd\u03cd\u03bf\u03c5\u03bd \u03ba\u03b1\u03b8\u03b7\u03bc\u03b5\u03c1\u03b9\u03bd\u03ac \u03cc\u03c4\u03b9 \u03bb\u03b5\u03b9\u03c4\u03bf\u03c5\u03c1\u03b3\u03bf\u03cd\u03bd \u03bc\u03b5 \u03c0\u03bb\u03ae\u03c1\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. \u03a4\u03bf ISO 13485 \u03b1\u03c0\u03bf\u03c4\u03b5\u03bb\u03b5\u03af \u03c4\u03bf \u03b2\u03b1\u03c3\u03b9\u03ba\u03cc \u03b4\u03b9\u03b5\u03b8\u03bd\u03ad\u03c2 \u03c0\u03c1\u03cc\u03c4\u03c5\u03c0\u03bf \u03b4\u03b9\u03b1\u03c7\u03b5\u03af\u03c1\u03b9\u03c3\u03b7\u03c2 \u03c0\u03bf\u03b9\u03cc\u03c4\u03b7\u03c4\u03b1\u03c2 \u03b3\u03b9\u03b1 \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. \u0397 \u03c0\u03b9\u03c3\u03c4\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7 \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd  [&#8230;]<\/p>\n","protected":false},"author":2,"featured_media":14134,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[38],"tags":[43],"class_list":["post-14133","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-38","tag-iso"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 13485 &amp; \u03a5\u0391 4822\/2025: \u039f\u03b4\u03b7\u03b3\u03cc\u03c2 \u03a3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7\u03c2 \u03b3\u03b9\u03b1 \u0399\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ac - \u039d\u03ad\u03c3\u03c4\u03c9\u03c1 \u03a3\u03c5\u03bc\u03b2\u03bf\u03c5\u03bb\u03b5\u03c5\u03c4\u03b9\u03ba\u03ae \u0391.\u0395.<\/title>\n<meta name=\"description\" content=\"\u039c\u03ac\u03b8\u03b5\u03c4\u03b5 \u03c4\u03b9 \u03b5\u03af\u03bd\u03b1\u03b9 \u03c4\u03bf ISO 13485 \u03ba\u03b1\u03b9 \u03c0\u03ce\u03c2 \u03c3\u03c5\u03bd\u03b4\u03ad\u03b5\u03c4\u03b1\u03b9 \u03bc\u03b5 \u03c4\u03b7\u03bd \u03a5\u0391 4822\/2025 \u03b3\u03b9\u03b1 \u03b5\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \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.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/www.nestor.com.gr\/en\/blog\/iso-13485-iatrotexnologika-proionta\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 &amp; \u03a5\u0391 4822\/2025: \u039f\u03b4\u03b7\u03b3\u03cc\u03c2 \u03a3\u03c5\u03bc\u03bc\u03cc\u03c1\u03c6\u03c9\u03c3\u03b7\u03c2 \u03b3\u03b9\u03b1 \u0399\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ac - \u039d\u03ad\u03c3\u03c4\u03c9\u03c1 \u03a3\u03c5\u03bc\u03b2\u03bf\u03c5\u03bb\u03b5\u03c5\u03c4\u03b9\u03ba\u03ae \u0391.\u0395.\" \/>\n<meta property=\"og:description\" content=\"\u039c\u03ac\u03b8\u03b5\u03c4\u03b5 \u03c4\u03b9 \u03b5\u03af\u03bd\u03b1\u03b9 \u03c4\u03bf ISO 13485 \u03ba\u03b1\u03b9 \u03c0\u03ce\u03c2 \u03c3\u03c5\u03bd\u03b4\u03ad\u03b5\u03c4\u03b1\u03b9 \u03bc\u03b5 \u03c4\u03b7\u03bd \u03a5\u0391 4822\/2025 \u03b3\u03b9\u03b1 \u03b5\u03c0\u03b9\u03c7\u03b5\u03b9\u03c1\u03ae\u03c3\u03b5\u03b9\u03c2 \u03b9\u03b1\u03c4\u03c1\u03bf\u03c4\u03b5\u03c7\u03bd\u03bf\u03bb\u03bf\u03b3\u03b9\u03ba\u03ce\u03bd 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