{"id":3806,"date":"2025-08-07T16:53:45","date_gmt":"2025-08-07T14:53:45","guid":{"rendered":"https:\/\/testwp.marcocammarata.it\/?page_id=141"},"modified":"2026-09-28T16:39:47","modified_gmt":"2026-09-28T14:39:47","slug":"post-market-support","status":"publish","type":"page","link":"https:\/\/www.we4cr.com\/it\/solutions\/post-market-support\/","title":{"rendered":"Post-Market Support"},"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\">Post-Market Services<\/h1>\n\n<p class=\"has-text-align-center has-base-font-size wp-block-paragraph\">For medical device manufacturers with products already on the market that need to generate ongoing clinical evidence and maintain post-market regulatory compliance.<\/p><\/div><style id=\"we4cr-postmarket-css\">.w4p{--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.w4p *,.w4p *::before,.w4p *::after{box-sizing:border-box}\r\n.w4p h2,.w4p h3,.w4p p{font-family:inherit;text-transform:none;letter-spacing:normal;margin:0;padding:0;background:none;border:0}\r\n.w4p .w4p-sec{position:relative;padding:56px 0}\r\n.w4p .w4p-sec--tint{background:var(--w4-tint)}\r\n.w4p .w4p-wrap{width:100%;max-width:1200px;margin:0 auto;padding:0 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.w4p-faq{grid-template-columns:minmax(0,4fr) minmax(0,7fr);gap:80px;max-width:none;margin:0;align-items:start}\r\n.w4p .w4p-qa__item{padding:0 32px}\r\n.w4p button.w4p-qa__trigger{padding:22px 0}\r\n.w4p .w4p-qa__inner p{padding-right:40px}\r\n}\r\n@media (prefers-reduced-motion:reduce){\r\n.w4p *,.w4p *::before,.w4p *::after{transition:none!important}\r\n}<\/style><div class=\"w4p\" id=\"w4p-1\"><section class=\"w4p-sec w4p-sec--light\" aria-label=\"Post-market services\"><div class=\"w4p-wrap\"><div class=\"w4p-cards\"><article class=\"w4p-card\"><div class=\"w4p-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 12h4l2.5-6 4 12 2.5-6H21\"\/><\/svg><\/div><h2 class=\"w4p-card__title\">PMCF - Post-Market Clinical Follow-up<\/h2><p class=\"w4p-card__text\">We draft the PMCF plan in accordance with the MDR and MDCG guidelines, carry out the planned activities and prepare the PMCF evaluation report, which feeds the clinical evaluation of the device.<\/p><\/article><article class=\"w4p-card\"><div class=\"w4p-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=\"w4p-card__title\">Vigilance management<\/h2><p class=\"w4p-card__text\">We manage the reporting of incidents and field safety corrective actions (FSCA) under the MDR vigilance system.<\/p><\/article><article class=\"w4p-card\"><div class=\"w4p-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=\"M12 6c-1.8-1.6-4.3-2.3-8-2.3v14.6c3.7 0 6.2.7 8 2.3 1.8-1.6 4.3-2.3 8-2.3V3.7c-3.7 0-6.2.7-8 2.3z\"\/><path d=\"M12 6v14.6\"\/><\/svg><\/div><h2 class=\"w4p-card__title\">Literature and safety signals<\/h2><p class=\"w4p-card__text\">We periodically monitor the scientific literature and analyze aggregated safety data, to detect in good time any signals about the device.<\/p><\/article><\/div><\/div><\/section><\/div><div class=\"w4p\" id=\"w4p-2\"><section class=\"w4p-sec w4p-sec--tint\" aria-labelledby=\"w4p-2-faq\"><div class=\"w4p-wrap\"><div class=\"w4p-faq\"><h2 class=\"w4p-h2\" id=\"w4p-2-faq\">People also ask\u2026<\/h2><div class=\"w4p-qa\" data-open-first=\"1\"><div class=\"w4p-qa__item\" data-open=\"1\"><h3 class=\"w4p-qa__h\"><button type=\"button\" class=\"w4p-qa__trigger\" id=\"w4p-2-q-b0\" aria-expanded=\"true\" aria-controls=\"w4p-2-q-p0\"><span class=\"w4p-qa__label\">Are PMCF and PMS the same thing?<\/span><span class=\"w4p-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4p-qa__panel\" id=\"w4p-2-q-p0\" role=\"region\" aria-labelledby=\"w4p-2-q-b0\"><div class=\"w4p-qa__inner\"><p>No: post-market surveillance (PMS) is the general obligation to collect and analyze post-market data; PMCF is the active clinical follow-up component that generates specific clinical data, required for most medical devices under the MDR.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Are PMCF and PMS the same thing?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"No: post-market surveillance (PMS) is the general obligation to collect and analyze post-market data; PMCF is the active clinical follow-up component that generates specific clinical data, required for most medical devices under the MDR.\"}}]}<\/script><script>(function(){var 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