{"id":135,"date":"2025-08-07T16:53:26","date_gmt":"2025-08-07T14:53:26","guid":{"rendered":"https:\/\/testwp.marcocammarata.it\/?page_id=135"},"modified":"2026-09-28T16:30:21","modified_gmt":"2026-09-28T14:30:21","slug":"regulatory-services","status":"publish","type":"page","link":"https:\/\/www.we4cr.com\/it\/solutions\/regulatory-services\/","title":{"rendered":"Servizi Regolatori"},"content":{"rendered":"<div class=\"wp-block-group alignfull is-style-default has-tertiary-background-color has-background has-global-padding is-content-justification-center is-layout-constrained wp-container-core-group-is-layout-d491b7b6 wp-block-group-is-layout-constrained\" style=\"padding-top:var(--wp--preset--spacing--xx-large);padding-bottom:var(--wp--preset--spacing--xx-large)\"><p class=\"has-text-align-center has-primary-color has-text-color has-base-font-size wp-block-paragraph\" style=\"font-style:normal;font-weight:600\">By Strategic Area<\/p>\n\n<h1 class=\"wp-block-heading has-text-align-center has-large-font-size\">Regulatory Services &#8211; We4 Regulatory<\/h1>\n\n<p class=\"has-text-align-center has-base-font-size wp-block-paragraph\">For medical device manufacturers navigating the regulatory pathway to CE marking for their products in Europe, including clinical investigations, clinical evaluation, and post-market surveillance.<\/p><\/div><div style=\"height:44px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div><div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\"><p class=\"has-text-align-center wp-block-paragraph\">We4 Regulatory is the regulatory consulting division of We4 Clinical Research S.r.l., dedicated to providing regulatory support for medical devices. It is not a separate legal entity, and all regulatory services are invoiced by We4 Clinical Research.<\/p>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-b7c91e0b wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-button-brand is-style-button-brand--1\"><a class=\"wp-block-button__link has-text-align-center has-base-font-size has-custom-font-size wp-element-button\" href=\"#form\">Let&#8217;s talk<\/a><\/div><\/div><\/div><style id=\"we4cr-regulatory-css\">.w4r{--w4-navy:#0B2A4A;--w4-teal:#0A7F8A;--w4-tint:#EAF5F7;--w4-line:#D3E2E7;--w4-text:#3A4E62;--w4-mint:#9BDCE2;font-family:'Poppins',sans-serif;font-size:16px;line-height:1.65;color:var(--w4-text);max-width:100%;overflow-x:clip;-webkit-font-smoothing:antialiased}\r\n.w4r *,.w4r *::before,.w4r *::after{box-sizing:border-box}\r\n.w4r h2,.w4r h3,.w4r 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2;padding:36px 32px;border-radius:28px}\r\n.w4r .w4r-card{grid-column:span 3}\r\n.w4r .w4r-icon{width:60px;height:60px;border-radius:18px}\r\n.w4r .w4r-faq{grid-template-columns:minmax(0,4fr) minmax(0,7fr);gap:80px;max-width:none;margin:0;align-items:start}\r\n.w4r .w4r-qa__item{padding:0 32px}\r\n.w4r button.w4r-qa__trigger{padding:22px 0}\r\n.w4r .w4r-qa__inner p{padding-right:40px}\r\n}\r\n@media (prefers-reduced-motion:reduce){\r\n.w4r *,.w4r *::before,.w4r *::after{transition:none!important}\r\n}<\/style><div class=\"w4r\" id=\"w4r-1\"><section class=\"w4r-sec w4r-sec--light\" aria-label=\"Regulatory services\"><div class=\"w4r-wrap\"><div class=\"w4r-cards\"><article class=\"w4r-card\"><div class=\"w4r-icon\"><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.6\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\" focusable=\"false\"><path d=\"M14 3H7a2 2 0 0 0-2 2v14a2 2 0 0 0 2 2h10a2 2 0 0 0 2-2V8z\"\/><path d=\"M14 3v5h5\"\/><path d=\"M12 11.5v5M9.5 14h5\"\/><\/svg><\/div><h2 class=\"w4r-card__title\">Technical documentation and clinical evaluation<\/h2><p class=\"w4r-card__text\">We contribute to the Clinical Evaluation Report (CER), support the completion of the checklist of General Safety and Performance Requirements (GSPR) and review the Investigator\u2019s Brochure and instructions for use, for consistency between clinical data and regulatory documentation.<\/p><\/article><article class=\"w4r-card\"><div class=\"w4r-icon\"><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.6\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\" focusable=\"false\"><path d=\"M9 3h6\"\/><path d=\"M10 3v6l-5.2 9a1.8 1.8 0 0 0 1.6 2.7h11.2a1.8 1.8 0 0 0 1.6-2.7L14 9V3\"\/><path d=\"M7.5 15h9\"\/><\/svg><\/div><h2 class=\"w4r-card__title\">Clinical investigations on devices (ISO 14155)<\/h2><p class=\"w4r-card__text\">We draft the Clinical Investigation Plan (CIP) in accordance with ISO 14155 and the MDR and take care of its registration in EUDAMED when required, working with the clinical team that will conduct the study.<\/p><\/article><article class=\"w4r-card\"><div class=\"w4r-icon\"><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.6\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\" focusable=\"false\"><path d=\"M3 9l9-5 9 5\"\/><path d=\"M5 9v9M9.5 9v9M14.5 9v9M19 9v9\"\/><path d=\"M3 21h18\"\/><\/svg><\/div><h2 class=\"w4r-card__title\">Notified Body relations<\/h2><p class=\"w4r-card__text\">We support you in your interactions with the Notified Body: preparing answers to questions and following up on the documentation requested.<\/p><\/article><article class=\"w4r-card\"><div class=\"w4r-icon\"><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.6\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\" focusable=\"false\"><path d=\"M6 16v-5a6 6 0 0 1 12 0v5l1.5 2h-15z\"\/><path d=\"M10 21h4\"\/><\/svg><\/div><h2 class=\"w4r-card__title\">Vigilance and post-market follow-up<\/h2><p class=\"w4r-card__text\">We manage the vigilance reports required by the MDR (incidents and field safety corrective actions, FSCA) and draft the PMCF plan and report: details are on the Post-market services page.<\/p><\/article><\/div><\/div><\/section><\/div><div class=\"w4r\" id=\"w4r-2\"><section class=\"w4r-sec w4r-sec--tint\" aria-labelledby=\"w4r-2-faq\"><div class=\"w4r-wrap\"><div class=\"w4r-faq\"><h2 class=\"w4r-h2\" id=\"w4r-2-faq\">FAQ \u2014 Regulatory services<\/h2><div class=\"w4r-qa\" data-open-first=\"1\"><div class=\"w4r-qa__item\" data-open=\"1\"><h3 class=\"w4r-qa__h\"><button type=\"button\" class=\"w4r-qa__trigger\" id=\"w4r-2-q-b0\" aria-expanded=\"true\" aria-controls=\"w4r-2-q-p0\"><span class=\"w4r-qa__label\">Can you confirm the MDR class of our device before we start?<\/span><span class=\"w4r-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4r-qa__panel\" id=\"w4r-2-q-p0\" role=\"region\" aria-labelledby=\"w4r-2-q-b0\"><div class=\"w4r-qa__inner\"><p>MDR classification has to be assessed case by case on your specific product: we do not anticipate a class without having analyzed the documentation. It is the first step of the work we do together.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Can you confirm the MDR class of our device before we start?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"MDR classification has to be assessed case by case on your specific product: we do not anticipate a class without having analyzed the documentation. 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We4 Regulatory is the regulatory consulting division of We4 Clinical Research S.r.l., dedicated to providing regulatory support for medical devices. It is not [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":75,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-no-title","meta":{"footnotes":""},"class_list":["post-135","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Regulatory Services | We4 Clinical Research<\/title>\n<meta name=\"description\" content=\"By Strategic Area Regulatory Services - We4 Regulatory For medical device manufacturers navigating the regulatory pathway to CE marking for their products\" \/>\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.we4cr.com\/it\/solutions\/regulatory-services\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Services | We4 Clinical Research\" \/>\n<meta property=\"og:description\" content=\"By Strategic Area Regulatory Services - 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