{"id":688,"date":"2022-09-06T14:27:54","date_gmt":"2022-09-06T12:27:54","guid":{"rendered":"https:\/\/www.biotopmedical.nl\/technische-documentatie\/medical-devices-regulations\/clinical-evaluation\/"},"modified":"2024-04-23T16:26:23","modified_gmt":"2024-04-23T14:26:23","slug":"klinische-evaluatie","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/klinische-evaluatie\/","title":{"rendered":"Klinische \/ Prestatie evaluatie"},"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  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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\/nl\/persoon-verantwoordelijk-voor-de-naleving-van-de-regelgeving\/\">Person Responsible for Regulatory Compliance (PRRC)<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            \">Klinische \/ Prestatie evaluatie<\/h1>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>BioTop Medical heeft uitgebreide ervaring met klinische\/prestatie-evaluatie. Wij volgen de eisen van de MDR\/IVDR. We schrijven het plan, voeren een objectieve analyse uit en schrijven de conclusies. Wij leveren de expertise op het gebeid van de evaluatiemethodiek en zorgen ervoor dat aan de eisen van de regelgeving wordt voldaan.<\/p>\n\r\n        <\/div>[vc_row_inner content_placement=&#8221;middle&#8221;][vc_column_inner width=&#8221;1\/3&#8243;]\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\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>Het antwoord luidt als volgt: de eerste stap is een training van de cli\u00ebnt zodat wij volledig op de hoogte zijn van de medische toepassing van het hulpmiddel, inclusief de werkingsprincipes, de werkingswijze en bekende alternatieve technologie\u00ebn. Op grond van deze informatie kunnen wij het literatuuronderzoeksprotocol opstellen dat de opdrachtgever beoordeelt en goedkeurt voordat wij met het onderzoek starten. Tijdens het literatuuronderzoek blijft onze kennis over de toepassing van het hulpmiddel, de technologie ervan en de alternatieve technologie\u00ebn toenemen. Pas na dit eerste literatuuronderzoek (om de stand van zaken op het gebied van de toepassing van het hulpmiddel vast te stellen) zullen we overgaan tot de klinische of prestatie-evaluatie. Op deze manier kunnen wij onze ervaring met het uitvoeren van deze evaluaties combineren met de kennis van onze klant over het specifieke medische hulpmiddel.<\/p>\n\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;2\/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\/09\/clinical-evaluation.png\" 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>Onze (medisch) wetenschappelijke achtergrond, onze ervaring met een breed scala aan medische hulpmiddelen en onze deskundigheid op het gebied van evaluatiemethodes stellen ons in staat snel de specifieke kennis op te doen die nodig is om de evaluatie uit te voeren.<\/p>\n<p>De klinische of prestatie-evaluatie is de beoordeling en analyse van datasets die betrekking hebben op een medisch hulpmiddel om aan te tonen dat ze in overeenstemming zijn met een aantal MDR\/IVDR Algemene Veiligheids- en Prestatievereisten (GSPRs) met betrekking tot het bereiken van het geclaimde beoogde gebruik van het hulpmiddel, de prestatie-effectiviteit, voordelen en veiligheid, waarvoor klinische gegevens nodig zijn.<\/p>\n<p>Klinische gegevens kunnen verkregen worden uit \u00e9\u00e9n of meer bronnen (bijvoorbeeld literatuur, preklinische gegevens, klinische gegevens) en het proces moet worden uitgevoerd volgens een vastgestelde en gedegen methodologie zoals beschreven in Artikel 61 en bijlage XIV van de MDR \/ Artikel 56 en bijlage XIII van de IVDR. Bovendien moet de evaluatie onbevooroordeeld zijn: grondig en objectief, waarbij zowel gunstige als ongunstige gegevens in ogenschouw worden genomen.<\/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; 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