{"id":902,"date":"2024-02-19T14:37:14","date_gmt":"2024-02-19T13:37:14","guid":{"rendered":"https:\/\/www.biotopmedical.nl\/?page_id=902"},"modified":"2024-04-30T11:25:04","modified_gmt":"2024-04-30T09:25:04","slug":"systematisch-literatuuronderzoek","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/systematisch-literatuuronderzoek\/","title":{"rendered":"Systematisch literatuuronderzoek"},"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            \">Services<\/h3>\r\n        <\/div><ul><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/quality-management-system\/\">Quality Management System<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><ul class=\"sub-menu\"><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/quality-management-system\/qms-implementation\/\">QMS Implementation<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><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/quality-management-system\/auditing\/\">Auditing<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><\/a>\r\n                            <\/li><\/ul><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/\">Technical Documentation File<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><ul class=\"sub-menu\"><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/medical-device-risk-management\/\">Medical device risk management<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><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/clinical-evaluation-mdr\/\">Clinical Evaluation &#038; 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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            \">Technische Documentatie<\/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            \">Systematisch Literatuur Onderzoek<\/h1>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>Systematisch, objectief literatuuronderzoek is een verplichte bron van klinische gegevens. BioTop Medical heeft ruime ervaring met systematisch literatuuronderzoek: het schrijven van het protocol omvat het vaststellen van de zoekvraag met behulp van de PICO-methode, het vaststellen van objectieve criteria voor de selectie en beoordeling van de literatuur, het opstellen van een plan om gegevens uit de geselecteerde publicaties te halen en de analyse van die gegevens. Wij leveren de expertise op het gebied van de zoekmethodiek en zorgen ervoor dat aan de eisen van de regelgeving wordt voldaan.<\/p>\n<p>Cli\u00ebnten vragen vaak: &#8220;Hoe kun je literatuuronderzoek doen zonder expert te zijn op het gebied van een specifiek medisch hulpmiddel?&#8221;<\/p>\n<p>In essentie is een systematisch literatuuronderzoek een methode om gegevens te verzamelen. We bepalen en volgen het protocol voor een systematische en objectieve methode, waarbij we de precieze informatie die we nodig hebben extraheren gerelateerd aan het doel van het literatuuronderzoek. De eerste stap is dat de klant ons traint in de medische toepassing van het hulpmiddel, inclusief de werkingsprincipes, de werkingswijze en bekende alternatieve technologie\u00ebn. Met deze informatie kunnen wij het literatuuronderzoeksprotocol opstellen dat de opdrachtgever beoordeelt en goedkeurt voordat wij met de zoekopdracht beginnen.<\/p>\n<p>Onze (medisch-)wetenschappelijke achtergrond en ervaring met een breed scala aan medische hulpmiddelen en expertise in de zoekmethode, stelt ons in staat snel de specifieke kennis op te doen die we nodig hebben om de zoekopdracht uit te voeren.<\/p>\n<p>We gebruiken de richtlijnen van MEDDEV 2.7\/1 en volgen de PRISMA-methode om literatuuronderzoek uit te voeren voor verschillende doelen. Het doel van het literatuuronderzoek kan bijvoorbeeld zijn:<\/p>\n<ul>\n<li>Bepalen of een te ontwikkelen hulpmiddel &#8220;state-of-the-art&#8221; is vroeg in de ontwikkeling van het hulpmiddel: klinische literatuur\/incidenten vinden die gemeld zijn over vergelijkbare en alternatieve technologie\u00ebn van het hulpmiddel.<\/li>\n<li>Gebruiken als klinische data in de klinische\/prestatie-evaluatie van het hulpmiddel wanneer gelijkwaardigheid met een ander hulpmiddel op de markt wordt geclaimd: gepubliceerde pre- en klinische onderzoeken\/incidenten die gemeld zijn over het\/de gelijkwaardige hulpmiddel(en).<\/li>\n<li>Gebruiken als onderdeel van het post-marketing surveillanceplan gedurende de gehele levenscyclus van het medische hulpmiddel.<\/li>\n<li>Het onderwerp te zijn van de post-market klinische follow-up (PMCF).<\/li>\n<\/ul>\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\/contact-us\/\" title=\"Get in touch\">Get in touch<\/a>\r\n        <\/div>[\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; 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