{"id":312,"date":"2023-12-13T13:49:58","date_gmt":"2023-12-13T13:49:58","guid":{"rendered":"https:\/\/newwebsite.linguamed.hu\/?page_id=312"},"modified":"2024-05-29T11:05:23","modified_gmt":"2024-05-29T11:05:23","slug":"orvostechnikai-eszkozok","status":"publish","type":"page","link":"http:\/\/linguamed.hu\/en\/orvostechnikai-eszkozok\/","title":{"rendered":"Medical devices (MD)"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1 class=\"post-title\" style=\"text-align: center;\">Orvostechnikai eszk\u00f6z\u00f6k<\/h1>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Az orvostechnikai eszk\u00f6z\u00f6k gy\u00e1rt\u00e1s\u00e1ra, forgalmaz\u00e1s\u00e1ra \u00e9s rekl\u00e1moz\u00e1s\u00e1ra rendk\u00edv\u00fcl szigor\u00fa uni\u00f3s \u00e9s helyi jogi szab\u00e1lyoz\u00e1s vonatkozik. \u00c9ppen ez\u00e9rt elengedhetetlen, hogy az orvostechnikai eszk\u00f6z\u00f6kh\u00f6z kapcsol\u00f3d\u00f3 minden egyes dokumentum pontos \u00e9s szakmailag kifog\u00e1stalan ford\u00edt\u00e1st kapjon. Ez nemcsak a vonatkoz\u00f3 jogszab\u00e1lyok betart\u00e1sa, hanem a biztons\u00e1gos haszn\u00e1lat \u00e9rdek\u00e9ben is l\u00e9nyeges.<\/p>\n<p>Az orvostechnikai eszk\u00f6z\u00f6knek egy speci\u00e1lis enged\u00e9lyeztet\u00e9si folyamaton kell \u00e1tesni\u00fck a forgalomba hozatalukat megel\u0151z\u0151en, ahol megfelel\u0151s\u00e9g\u00e9rt\u00e9kel\u00e9s sor\u00e1n \u00e1llap\u00edtj\u00e1k meg, hogy az adott term\u00e9k megfelel-e a vonatkoz\u00f3 szabv\u00e1nyoknak, \u00e9s elhelyezhet\u0151 rajta a CE megfelel\u0151s\u00e9gi jel\u00f6l\u00e9s. Mivel ez egy rendk\u00edv\u00fcl \u00f6sszetett folyamat, ford\u00edt\u00f3irod\u00e1nk az enged\u00e9lyeztet\u00e9si elj\u00e1r\u00e1s valamennyi f\u00e1zis\u00e1ban seg\u00edts\u00e9get ny\u00fajt a szakszer\u0171 orvosi ford\u00edt\u00e1sok elk\u00e9sz\u00edt\u00e9s\u00e9ben, legyen sz\u00f3 b\u00e1rmilyen \u00e1ltal\u00e1nos (MDD), akt\u00edv be\u00fcltethet\u0151 (AIMD), vagy in vitro diagnosztikai (IVD) orvostechnikai eszk\u00f6zr\u0151l.<\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Orvostechnikai eszk\u00f6z\u00f6kkel kapcsolatos dokumentumok ford\u00edt\u00e1sa:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>megfelel\u0151s\u00e9g\u00e9rt\u00e9kel\u00e9si elj\u00e1r\u00e1shoz kapcsol\u00f3d\u00f3 dokumentumok (gy\u00e1rtm\u00e1nyterv tan\u00fas\u00edt\u00e1s, gy\u00e1rt\u00f3i megfelel\u0151s\u00e9gi nyilatkozat, t\u00edpusvizsg\u00e1lati tan\u00fas\u00edt\u00e1s)<\/li>\n<li>klinikai \u00e9rt\u00e9kel\u00e9s<\/li>\n<li>c\u00edmkesz\u00f6veg<\/li>\n<li>haszn\u00e1lati \u00fatmutat\u00f3<\/li>\n<li>m\u0171szaki dokument\u00e1ci\u00f3 (pl.: orvostechnikai eszk\u00f6z le\u00edr\u00e1s, haszn\u00e1lati \u00fatmutat\u00f3ja, kock\u00e1zatir\u00e1ny\u00edt\u00e1si dokumentumok, elv\u00e9gzett vizsg\u00e1latok, tesztek eredm\u00e9nyei, EK megfelel\u0151s\u00e9gi nyilatkozat)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;22px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\"><span>K\u00e9rje ingyenes\u00a0<\/span>\u00e1raj\u00e1nlatunkat<span> orvostechnikai eszk\u00f6z\u00f6kh\u00f6z kapcsol\u00f3d\u00f3 dokumentumok ford\u00edt\u00e1s\u00e1ra!<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_button button_url=&#8221;\/ajanlatkeres\/&#8221; button_text=&#8221;Aj\u00e1nlatot k\u00e9rek&#8221; button_alignment=&#8221;center&#8221; _builder_version=&#8221;4.20.4&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Orvostechnikai eszk\u00f6z\u00f6kAz orvostechnikai eszk\u00f6z\u00f6k gy\u00e1rt\u00e1s\u00e1ra, forgalmaz\u00e1s\u00e1ra \u00e9s rekl\u00e1moz\u00e1s\u00e1ra rendk\u00edv\u00fcl szigor\u00fa uni\u00f3s \u00e9s helyi jogi szab\u00e1lyoz\u00e1s vonatkozik. \u00c9ppen ez\u00e9rt elengedhetetlen, hogy az orvostechnikai eszk\u00f6z\u00f6kh\u00f6z kapcsol\u00f3d\u00f3 minden egyes dokumentum pontos \u00e9s szakmailag kifog\u00e1stalan ford\u00edt\u00e1st kapjon. Ez nemcsak a vonatkoz\u00f3 jogszab\u00e1lyok betart\u00e1sa, hanem a biztons\u00e1gos haszn\u00e1lat \u00e9rdek\u00e9ben is l\u00e9nyeges. Az orvostechnikai eszk\u00f6z\u00f6knek egy speci\u00e1lis enged\u00e9lyeztet\u00e9si folyamaton kell \u00e1tesni\u00fck [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-312","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"http:\/\/linguamed.hu\/en\/wp-json\/wp\/v2\/pages\/312","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/linguamed.hu\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/linguamed.hu\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/linguamed.hu\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/linguamed.hu\/en\/wp-json\/wp\/v2\/comments?post=312"}],"version-history":[{"count":6,"href":"http:\/\/linguamed.hu\/en\/wp-json\/wp\/v2\/pages\/312\/revisions"}],"predecessor-version":[{"id":469,"href":"http:\/\/linguamed.hu\/en\/wp-json\/wp\/v2\/pages\/312\/revisions\/469"}],"wp:attachment":[{"href":"http:\/\/linguamed.hu\/en\/wp-json\/wp\/v2\/media?parent=312"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}