{"id":1893,"date":"2022-04-06T09:55:26","date_gmt":"2022-04-06T09:55:26","guid":{"rendered":"https:\/\/shirobusiness.com\/?page_id=1893"},"modified":"2023-08-24T12:49:21","modified_gmt":"2023-08-24T12:49:21","slug":"qa-ra-consulting-services","status":"publish","type":"page","link":"https:\/\/shirobusiness.com\/qa-ra-consulting-services\/","title":{"rendered":"Medical Device QA\/RA Outsourcing Services"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1893\" class=\"elementor elementor-1893\">\n\t\t\t\t\t\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-529a7503 elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"529a7503\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-67dc176f ae-bg-gallery-type-default\" data-id=\"67dc176f\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5f0c6c2d elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"5f0c6c2d\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInDown&quot;,&quot;_animation_tablet&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Medical Device QA\/RA Outsourcing Services<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-6f85c42f elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"6f85c42f\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-43cb87ac ae-bg-gallery-type-default\" data-id=\"43cb87ac\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-11e27e23 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"11e27e23\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;,&quot;_animation_tablet&quot;:&quot;none&quot;,&quot;_animation_delay&quot;:500}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/shirobusiness.com\/wp-content\/uploads\/elementor\/thumbs\/iStock-155392145_800px-pu0tnmr3sa2uumnf1sokuyde2di4ugknd8yglwzg10.jpg\" title=\"iStock-155392145_800px\" alt=\"an operation taking place blurred out in the background, to represent QA\/RA Consulting Services\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-269479bd ae-bg-gallery-type-default\" data-id=\"269479bd\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-47964aa1 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"47964aa1\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;,&quot;_animation_tablet&quot;:&quot;none&quot;,&quot;_animation_delay&quot;:600}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><span style=\"font-weight: 400;\">Now that the UK has left the EU, <\/span><b>all<\/b><span style=\"font-weight: 400;\"> medical device and IVD manufacturers based in the UK <\/span><b>MUST<\/b><span style=\"font-weight: 400;\"> designate an <a href=\"https:\/\/shirobusiness.com\/importer\/eu-authorised-representative\/\">Authorised European Representative (EC REP)<\/a> who is based in a full member state.<\/span><\/p><p><span style=\"background-color: var( --e-global-color-88d165b ); color: var(--ast-global-color-3); font-style: inherit; font-weight: inherit;\">Via our partners based in Cork, Ireland, we will ensure a smooth initial registration or transfer over to the <a href=\"http:\/\/www.hpra.ie\/homepage\/medical-devices\/regulatory-information\">Irish Competent Authority (HPRA)<\/a>.<\/span><\/p><p><span style=\"font-weight: 400;\">Several new AER companies have \u2018sprouted up\u2019 since this new requirement came about due to \u2018Brexit\u2019 and is now law (according to the new <a href=\"https:\/\/www.gov.uk\/guidance\/medical-devices-eu-regulations-for-mdr-and-ivdr\">MDR and IVDR Regulations<\/a>). Do they have a solid track record of assisting their clients? We do, and we can provide references upon request who will attest to our professionalism.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-54116bdc elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"54116bdc\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4751c785 ae-bg-gallery-type-default\" data-id=\"4751c785\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4c7c82b3 elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"4c7c82b3\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_tablet&quot;:&quot;none&quot;,&quot;_animation_delay&quot;:800}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-widget-divider{--divider-border-style:none;--divider-border-width:1px;--divider-color:#0c0d0e;--divider-icon-size:20px;--divider-element-spacing:10px;--divider-pattern-height:24px;--divider-pattern-size:20px;--divider-pattern-url:none;--divider-pattern-repeat:repeat-x}.elementor-widget-divider .elementor-divider{display:flex}.elementor-widget-divider .elementor-divider__text{font-size:15px;line-height:1;max-width:95%}.elementor-widget-divider .elementor-divider__element{margin:0 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.elementor-divider-separator>.elementor-divider__svg:first-of-type{flex-grow:0;flex-shrink:100}.elementor-widget-divider--element-align-left .elementor-divider-separator:before{content:none}.elementor-widget-divider--element-align-left .elementor-divider__element{margin-left:0}.elementor-widget-divider--element-align-right .elementor-divider .elementor-divider-separator>.elementor-divider__svg:last-of-type{flex-grow:0;flex-shrink:100}.elementor-widget-divider--element-align-right .elementor-divider-separator:after{content:none}.elementor-widget-divider--element-align-right .elementor-divider__element{margin-right:0}.elementor-widget-divider:not(.elementor-widget-divider--view-line_text):not(.elementor-widget-divider--view-line_icon) .elementor-divider-separator{border-top:var(--divider-border-width) var(--divider-border-style) var(--divider-color)}.elementor-widget-divider--separator-type-pattern{--divider-border-style:none}.elementor-widget-divider--separator-type-pattern.elementor-widget-divider--view-line .elementor-divider-separator,.elementor-widget-divider--separator-type-pattern:not(.elementor-widget-divider--view-line) .elementor-divider-separator:after,.elementor-widget-divider--separator-type-pattern:not(.elementor-widget-divider--view-line) .elementor-divider-separator:before,.elementor-widget-divider--separator-type-pattern:not([class*=elementor-widget-divider--view]) .elementor-divider-separator{width:100%;min-height:var(--divider-pattern-height);-webkit-mask-size:var(--divider-pattern-size) 100%;mask-size:var(--divider-pattern-size) 100%;-webkit-mask-repeat:var(--divider-pattern-repeat);mask-repeat:var(--divider-pattern-repeat);background-color:var(--divider-color);-webkit-mask-image:var(--divider-pattern-url);mask-image:var(--divider-pattern-url)}.elementor-widget-divider--no-spacing{--divider-pattern-size:auto}.elementor-widget-divider--bg-round{--divider-pattern-repeat:round}.rtl .elementor-widget-divider .elementor-divider__text{direction:rtl}.e-con-inner>.elementor-widget-divider,.e-con>.elementor-widget-divider{width:var(--container-widget-width,100%);--flex-grow:var(--container-widget-flex-grow)}<\/style>\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75450e4d elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"75450e4d\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_tablet&quot;:&quot;none&quot;,&quot;_animation_delay&quot;:1000}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">We have been an AER for over seventeen (17) years and offer the following support as part of our service:<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><p><b>&#8211; Dual registration<\/b><span style=\"font-weight: 400;\"> within the UK and Ireland for full EU compliance<\/span><\/p><p><b>&#8211; One fee<\/b><span style=\"font-weight: 400;\"> (not two) to cover both the UK <\/span><b>and<\/b><span style=\"font-weight: 400;\"> Irish support services<\/span><\/p><p><span style=\"font-weight: 400;\">&#8211; Significantly reduced costs due to registering \u2018en-block\u2019 with our other clients\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">&#8211; <\/span><span style=\"font-weight: 400;\">Assistance with <\/span><b>device labelling\/artwork<\/b><\/p><p><b>&#8211; Regulatory guidance<\/b><span style=\"font-weight: 400;\"> should your device be involved in an <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK208615\/\"><b>Adverse Event (AE)<\/b><\/a><\/p><p><span style=\"font-weight: 400;\">&#8211; Guidance on the <\/span><b>transition<\/b><span style=\"font-weight: 400;\"> from the <\/span><b>MDD \/ IVDD<\/b><span style=\"font-weight: 400;\"> to the <\/span><b>MDR \/ IVDR Regulations<\/b><span style=\"font-weight: 400;\">.<\/span><\/p><p><span style=\"font-weight: 400;\">&#8211; Assistance to find an <\/span><b>alternative Notified Body<\/b><span style=\"font-weight: 400;\">, should your UK <a href=\"https:\/\/single-market-economy.ec.europa.eu\/single-market\/goods\/building-blocks\/notified-bodies_en\">Notified Body<\/a> be <\/span><b>unable to support<\/b><span style=\"font-weight: 400;\"> their ISO 13485:2016 \/ CE Marking certification.<\/span><\/p><p><span style=\"font-weight: 400;\">Almost mirroring the services outlined above, post-Brexit, it is now required for manufacturers outside the UK to have a <a href=\"https:\/\/shirobusiness.com\/importer\/uk-responsible-person\/\">UK Responsible Person (UKRP)<\/a> mandated. This is also a service that we provide regularly.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-21b47b94 elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"21b47b94\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_top&quot;:&quot;tilt&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-shape elementor-shape-top\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 100\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M0,6V0h1000v100L0,6z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1d72e4d1 ae-bg-gallery-type-default\" data-id=\"1d72e4d1\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a647ffb elementor-widget elementor-widget-heading\" data-id=\"a647ffb\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"> Book Now For a Free, No Obligation Consultation<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3622285f elementor-align-center elementor-widget elementor-widget-button\" data-id=\"3622285f\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a href=\"https:\/\/shirobusiness.com\/contact\/\" class=\"elementor-button-link elementor-button elementor-size-sm\" role=\"button\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Click here<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical Device QA\/RA Outsourcing Services Now that the UK has left the EU, all medical device and IVD manufacturers based in the UK MUST designate an Authorised European Representative (EC REP) who is based in a full member state. Via our partners based in Cork, Ireland, we will ensure a smooth initial registration or transfer &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/shirobusiness.com\/?ae_global_templates=lh-news-block\"> <span class=\"screen-reader-text\">LH News Block<\/span> Read More &raquo;<\/a><\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device and IVDs QA\/RA Outsourcing<\/title>\n<meta name=\"description\" content=\"Shiro provides short term quality assurance (QA) and regulatory 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