{"id":921,"date":"2024-02-19T14:48:06","date_gmt":"2024-02-19T13:48:06","guid":{"rendered":"https:\/\/www.biotopmedical.nl\/?page_id=921"},"modified":"2024-04-30T09:54:07","modified_gmt":"2024-04-30T07:54:07","slug":"persoon-verantwoordelijk-voor-de-naleving-van-de-regelgeving","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/persoon-verantwoordelijk-voor-de-naleving-van-de-regelgeving\/","title":{"rendered":"Person Responsible for Regulatory Compliance (PRRC)"},"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  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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\/nl\/kwaliteitsmanagementsysteem\/qms-implementatie\/\">QMS implementatie<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\/nl\/technische-documentatie\/\">Technische Documentatie<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\/nl\/technische-documentatie\/risicomanagement\/\">Risicomanagement<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 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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\/nl\/technische-documentatie\/biologisch-evaluatierapport\/\">Biologische Evaluatie<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\/nl\/technische-documentatie\/overig\/\">Overig<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 current-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            \">Person Responsible for Regulatory Compliance (PRRC)<\/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>Fabrikanten maken de overstap naar of brengen hun producten op de markt onder de nieuwe regelgeving voor medische hulpmiddelen (MDR of IVDR). Een vereiste van de MDR en de IVDR is dat zij altijd een PRRC tot hun beschikking hebben. Wij vullen deze functie in voor kleine bedrijven in medische hulpmiddelen (minder dan 50 medewerkers).<\/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\/08\/Afbeelding1.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>De specifieke eisen die voor de PRRC gelden, maken het lastig voor kleine bedrijven iemand in dienst te hebben met de juiste opleiding en\/of ervaring zoals beschreven in de regelgeving inzake medische hulpmiddelen. Daarom staan de regels toe dat kleinere bedrijven een externe partij inhuren om de functie van PRRC in te vullen.<\/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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