{"id":223,"date":"2022-08-10T15:02:13","date_gmt":"2022-08-10T13:02:13","guid":{"rendered":"https:\/\/www.biotopmedical.nl\/medical-devices-regulations\/"},"modified":"2023-06-15T11:34:02","modified_gmt":"2023-06-15T09:34:02","slug":"wetgeving-medische-hulpmiddelen","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/wetgeving-medische-hulpmiddelen\/","title":{"rendered":"Wetgeving Medische Hulpmiddelen"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1662038703013{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;]\r\n        <div class=\"sd-block-menu  marginbottom-40px\r\n        \">\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-black\r\n            \">Technical Documentation File<\/h3>\r\n        <\/div><ul><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/medical-device-risk-management\/\">Medical device risk management<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/clinical-evaluation-mdr\/\">Clinical Evaluation &#038; MDR<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/systematic-literature-searches\/\">Systematic Literature Searches<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/biological-safety-assessment\/\">Biological Evaluation<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/other\/\">Other<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><\/ul>\r\n        <\/div>\r\n        <div class=\"sd-block-image  align-center marginbottom-40px snake-icon\r\n        \"><img decoding=\"async\" title=\"\" alt=\"\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/08\/snake-icon-v2-1.svg\" width=\"600\" height=\"500\">\r\n        <\/div>[vc_row_inner][vc_column_inner col_color=&#8221;bg_white&#8221;]\r\n        <div class=\"sd-block-text  marginbottom-0px color-black\r\n        \">\r\n            <p>Voor rechtstreeks contact belt u<br \/>\n<a href=\"tel:+31715280112\">+31 (0)71 528 01 12<\/a><strong><br \/>\n<\/strong><\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/12&#8243;][\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;2\/3&#8243; el_class=&#8221;right-sidebar&#8221;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-middle\r\n            \">Diensten<\/h2>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h1 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-middle\r\n            \">Wetgeving Medische Hulpmiddelen<\/h1>\r\n        <\/div>[vc_row_inner content_placement=&#8221;middle&#8221;][vc_column_inner width=&#8221;2\/3&#8243;]\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>BioTop Medical biedt advies op maat over de regelgevingsstrategie voor certificering van medische hulpmiddelen, evenals praktische ondersteuning bij het kwaliteitssysteem, het samenstellen van de Technische Documentatie van het hulpmiddel en de verplichte regelgevende documenten die in het dossier moeten worden opgenomen. Wij bieden onze klanten op maat gemaakte en kosteneffectieve oplossingen om hun medische hulpmiddelen in de Europese Unie en Noord-Amerika op de markt te brengen.<\/p>\n\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]\r\n        <div class=\"sd-block-image  align-center marginbottom-40px\r\n        \"><img decoding=\"async\" title=\"\" alt=\"\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/medical_devices_regulation.jpg\" width=\"600\" height=\"500\">\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner]\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>We blijven op de hoogte van de nieuwste wijzigingen in regelgeving en wijzigingen in normen en houden onze klanten op de hoogte. We faciliteren onze klanten om de nodige verbeteringen aan hun kwaliteitssystemen en medische hulpmiddelen aan te brengen om ervoor zorg te dragen dat de regelgeving continu wordt nageleefd.<\/p>\n\r\n        <\/div>\r\n        <div class=\"sd-block-button  marginbottom-40px style-solid color-purple\">\r\n            <a href=\"https:\/\/www.biotopmedical.nl\/nl\/neem-contact-met-ons-op\/\" title=\"Neem contact op\">Neem contact op<\/a>\r\n        <\/div>[\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1662038703013{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;][vc_row_inner][vc_column_inner col_color=&#8221;bg_white&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/12&#8243;][\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;2\/3&#8243; el_class=&#8221;right-sidebar&#8221;][vc_row_inner content_placement=&#8221;middle&#8221;][vc_column_inner width=&#8221;2\/3&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":663,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-223","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Wetgeving Medische Hulpmiddelen | BioTop Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/wetgeving-medische-hulpmiddelen\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Wetgeving Medische Hulpmiddelen | BioTop Medical\" \/>\n<meta property=\"og:description\" content=\"[vc_row full_width=&#8221;stretch_row&#8221; 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