{"id":10059,"date":"2026-09-03T10:00:00","date_gmt":"2026-09-03T09:00:00","guid":{"rendered":"https:\/\/gt-traducoes.pt\/?p=10059"},"modified":"2026-09-03T10:00:00","modified_gmt":"2026-09-03T09:00:00","slug":"medical-device-manufacturer-translation","status":"publish","type":"post","link":"https:\/\/gt-traducoes.pt\/en\/medical-device-manufacturer-translation\/","title":{"rendered":"Technical and clinical translation for medical device manufacturers"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10059\" class=\"elementor elementor-10059 elementor-10058 elementor-bc-flex-widget\">\n\t\t\t\t<div class=\"elementor-element elementor-element-643e441b e-flex e-con-boxed e-con e-parent\" data-id=\"643e441b\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7f105b82 elementor-widget elementor-widget-text-editor\" data-id=\"7f105b82\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"blog-details-content\"><style>@font-face {\n  font-family: \"FA Solid Local\";\n  font-style: normal; font-weight: 900;\n  font-display: block;\n  src: url(\"\/wp-content\/themes\/edcare\/assets\/fonts\/fa-solid-900.woff2\") format(\"woff2\");\n}\n@font-face {\n  font-family: \"FA Regular Local\";\n  font-style: normal; font-weight: 400;\n  font-display: block;\n  src: url(\"\/wp-content\/themes\/edcare\/assets\/fonts\/fa-regular-400.woff2\") format(\"woff2\");\n}\n@font-face {\n  font-family: \"FA Brands Local\";\n  font-style: normal; font-weight: 400;\n  font-display: block;\n  src: url(\"\/wp-content\/themes\/edcare\/assets\/fonts\/fa-brands-400.woff2\") format(\"woff2\");\n}\n.blog-details-content .fa-solid, .blog-details-content .fas { font-family: \"FA Solid Local\" !important; font-weight: 900 !important; font-style: normal !important; }\n.blog-details-content .fa-regular, .blog-details-content .far { font-family: \"FA Regular Local\" !important; font-weight: 400 !important; font-style: normal !important; }\n.blog-details-content .fa-brands, .blog-details-content .fab { font-family: \"FA Brands Local\" !important; font-weight: 400 !important; font-style: normal !important; }\n:root {\n  --gt-primary: #07A698;\n  --gt-primary-dark: #058579;\n  --gt-primary-darker: #044f47;\n  --gt-heading: #162726;\n  --gt-text: #4a5252;\n  --gt-text-soft: #6C706F;\n  --gt-bg-soft: #F7F9FA;\n  --gt-bg-card: #ffffff;\n  --gt-border: #E0E5EB;\n  --gt-accent-orange: #F58220;\n}\n.blog-details-content > h2:first-child { margin-top: 0; }\n.blog-details-content h2 {\n  color: var(--gt-heading);\n  font-size: 36px;\n  font-weight: 700;\n  margin-top: 64px;\n  margin-bottom: 22px;\n  line-height: 1.25;\n  letter-spacing: -0.02em;\n  position: relative;\n  padding-bottom: 14px;\n}\n.blog-details-content .cta-box + h2,\n.blog-details-content .cta-box-alt + h2,\n.blog-details-content .info-table-wrap + h2,\n.blog-details-content .highlight-box + h2,\n.blog-details-content .cert-grid + h2,\n.blog-details-content .problem-grid + h2,\n.blog-details-content .cases-grid + h2,\n.blog-details-content .why-grid + h2,\n.blog-details-content .doc-list + h2,\n.blog-details-content .faq + h2 { margin-top: 54px; }\n.blog-details-content h2:after {\n  content: \"\";\n  position: absolute;\n  bottom: 0; left: 0;\n  width: 60px; height: 4px;\n  background: linear-gradient(90deg, var(--gt-primary), var(--gt-primary-dark));\n  border-radius: 2px;\n}\n.blog-details-content h3 { color: var(--gt-heading); font-size: 22px; font-weight: 600; margin-top: 36px; }\n.blog-details-content p { color: var(--gt-text); font-size: 17px; line-height: 1.8; margin-bottom: 18px; }\n.blog-details-content ul, .blog-details-content ol { color: var(--gt-text); font-size: 17px; line-height: 1.9; }\n.blog-details-content ul li, .blog-details-content ol li { margin-bottom: 10px; }\n.blog-details-content a { color: var(--gt-primary); font-weight: 600; }\n.blog-details-content a:hover { color: var(--gt-primary-dark); }\n.blog-details-content strong { color: var(--gt-heading); font-weight: 600; }\n.blog-details-content > p:first-of-type { font-size: 20px; line-height: 1.7; color: var(--gt-heading); font-weight: 400; }\n.blog-details-content > p:first-of-type:first-letter { font-size: 64px; font-weight: 700; color: var(--gt-primary); float: left; line-height: 1; padding: 4px 12px 0 0; font-family: Outfit, sans-serif; }\n.blog-details-content .stats-bar + h2 + p:first-letter,\n.blog-details-content > .stats-bar + h2 + p:first-letter {  }\n.stats-bar {\n  display: grid;\n  grid-template-columns: repeat(4, 1fr);\n  gap: 0;\n  background: linear-gradient(135deg, var(--gt-heading) 0%, #0a1414 100%);\n  border-radius: 14px;\n  padding: 28px 0;\n  margin: 44px auto 40px;\n  max-width: 1140px;\n  position: relative;\n  z-index: 5;\n  box-shadow: 0 20px 60px rgba(7,166,152,0.18), 0 4px 16px rgba(0,0,0,0.08);\n}\n.stats-bar .stat { text-align: center; padding: 4px 16px; border-right: 1px solid rgba(255,255,255,0.08); }\n.stats-bar .stat:last-child { border-right: none; }\n.stats-bar .stat-num { display: block; font-size: 38px; font-weight: 800; color: #fff; line-height: 1; letter-spacing: -0.02em; }\n.stats-bar .stat-num .plus { color: var(--gt-primary); }\n.stats-bar .stat-label { display: block; font-size: 12px; color: rgba(255,255,255,0.7); margin-top: 8px; text-transform: uppercase; letter-spacing: 1.4px; font-weight: 500; }\n@media (max-width: 768px) {\n  .stats-bar { grid-template-columns: repeat(2, 1fr); margin-top: 22px; }\n  .stats-bar .stat { padding: 16px; border-bottom: 1px solid rgba(255,255,255,0.08); }\n  .stats-bar .stat:nth-child(odd) { border-right: 1px solid rgba(255,255,255,0.08); }\n  .stats-bar .stat:nth-child(3), .stats-bar .stat:nth-child(4) { border-bottom: none; }\n}\n.pull-quote {\n  background: var(--gt-bg-soft);\n  border-left: 5px solid var(--gt-primary);\n  padding: 32px 36px;\n  margin: 36px 0 36px;\n  border-radius: 0 12px 12px 0;\n  position: relative;\n  font-size: 22px;\n  line-height: 1.5;\n  color: var(--gt-heading);\n  font-weight: 500;\n  font-style: italic;\n}\n.pull-quote + p { margin-top: 18px; }\n.pull-quote:before {\n  content: none;\n  position: absolute;\n  top: -10px; right: 26px;\n  font-size: 100px;\n  color: var(--gt-primary);\n  opacity: 0.18;\n  font-family: Georgia, serif;\n  line-height: 1;\n}\n.cta-box {\n  background: linear-gradient(135deg, #0a8b80 0%, var(--gt-primary) 100%);\n  color: #fff;\n  padding: 38px 36px;\n  border-radius: 14px;\n  margin: 36px 0;\n  position: relative;\n  overflow: hidden;\n  box-shadow: 0 16px 50px rgba(7,166,152,0.25);\n}\n.cta-box:before {\n  content: \"\";\n  position: absolute;\n  top: -60px; right: -60px;\n  width: 220px; height: 220px;\n  background: rgba(255,255,255,0.06);\n  border-radius: 50%;\n}\n.cta-box:after {\n  content: \"\";\n  position: absolute;\n  bottom: -80px; right: 80px;\n  width: 160px; height: 160px;\n  background: rgba(255,255,255,0.04);\n  border-radius: 50%;\n}\n.cta-box > * { position: relative; z-index: 2; }\n.cta-box h3 { color: #fff !important; margin: 0 0 12px; font-size: 26px; font-weight: 700; line-height: 1.3; }\n.cta-box p { color: #ffffff !important; opacity: 1 !important; margin: 0 0 22px; font-size: 17px; line-height: 1.6; }\n.cta-btn { display: inline-flex; align-items: center; gap: 10px; background: #fff; color: var(--gt-primary-dark) !important; padding: 15px 30px; border-radius: 50px; font-weight: 700; text-decoration: none; margin: 4px 10px 4px 0; transition: all 0.25s; box-shadow: 0 6px 20px rgba(0,0,0,0.12); font-size: 15px; }\n.cta-btn:hover { background: var(--gt-heading); color: #fff !important; transform: translateY(-2px); box-shadow: 0 10px 28px rgba(0,0,0,0.2); }\n.cta-btn i { font-size: 16px; }\n.cta-btn-outline { background: transparent !important; color: #fff !important; border: 2px solid #fff; padding: 13px 28px; box-shadow: none; }\n.cta-btn-outline:hover { background: #fff !important; color: var(--gt-primary-dark) !important; }\n.cta-box-alt { background: linear-gradient(135deg, #0E121D 0%, var(--gt-heading) 100%); box-shadow: 0 16px 50px rgba(14,18,29,0.3); }\n.cta-box-alt .cta-btn { background: var(--gt-primary); color: #fff !important; }\n.cta-box-alt .cta-btn:hover { background: #fff; color: var(--gt-primary-dark) !important; }\n.cta-box-alt:before, .cta-box-alt:after { background: rgba(7,166,152,0.08); }\n.cta-box-final { background: linear-gradient(135deg, var(--gt-primary-dark) 0%, var(--gt-primary) 50%, #0a8b80 100%); text-align: center; padding: 56px 40px; margin: 50px 0 0; }\n.cta-box-final h3 { font-size: 30px; margin-bottom: 16px; }\n.cta-box-final .cta-btn-large { padding: 20px 44px; font-size: 17px; }\n.cta-box .badge-trust { display: inline-flex; align-items: center; gap: 8px; background: rgba(255,255,255,0.15); color: #fff !important; padding: 6px 14px; border-radius: 50px; font-size: 13px; font-weight: 600; margin-bottom: 14px; letter-spacing: 0.5px; }\n.cta-box strong, .cta-box b, .cta-box li, .cta-box span:not(.badge-fast) { color: #fff !important; }\n.cta-small { color: #fff !important; opacity: 0.92 !important; font-size: 14px; margin-top: 18px !important; }\n.cta-small a { color: #fff !important; text-decoration: underline; font-weight: 600; }\n.info-table-wrap { overflow-x: auto; border-radius: 12px; box-shadow: 0 6px 24px rgba(14,18,29,0.06); margin: 32px 0; border: 1px solid var(--gt-border); }\n.info-table { width: 100%; border-collapse: collapse; font-size: 15px; background: #fff; }\n.info-table thead { background: linear-gradient(135deg, var(--gt-heading) 0%, #0a1414 100%); }\n.info-table th { color: #fff; padding: 18px 22px; text-align: left; font-weight: 600; font-size: 14px; text-transform: uppercase; letter-spacing: 0.6px; }\n.info-table td { padding: 16px 22px; border-bottom: 1px solid #f0f3f5; color: var(--gt-text); }\n.info-table tbody tr { transition: background 0.15s; }\n.info-table tbody tr:hover { background: rgba(7,166,152,0.04); }\n.info-table tbody tr:last-child td { border-bottom: none; }\n.info-table td:first-child { font-weight: 600; color: var(--gt-heading); }\n.info-table .badge-fast { display: inline-block; background: rgba(245,130,32,0.12); color: var(--gt-accent-orange); padding: 4px 10px; border-radius: 50px; font-size: 12px; font-weight: 700; }\n.cert-grid, .problem-grid { display: grid; grid-template-columns: repeat(auto-fit, minmax(290px, 1fr)); gap: 24px; margin: 40px 0; }\n.cert-card, .problem-card {\n  background: #fff;\n  padding: 32px 28px;\n  border-radius: 14px;\n  border: 1px solid var(--gt-border);\n  position: relative;\n  transition: all 0.25s;\n  box-shadow: 0 4px 18px rgba(14,18,29,0.04);\n}\n.cert-card:hover, .problem-card:hover { transform: translateY(-4px); box-shadow: 0 14px 40px rgba(7,166,152,0.15); border-color: var(--gt-primary); }\n.cert-card .icon-wrap, .problem-card .icon-wrap {\n  width: 56px; height: 56px;\n  background: linear-gradient(135deg, var(--gt-primary), var(--gt-primary-dark));\n  border-radius: 14px;\n  display: flex; align-items: center; justify-content: center;\n  margin-bottom: 18px;\n  box-shadow: 0 8px 20px rgba(7,166,152,0.25);\n}\n.cert-card .icon-wrap i, .problem-card .icon-wrap i { color: #fff; font-size: 24px; }\n.cert-card h3, .problem-card h3 { color: var(--gt-heading) !important; font-size: 19px; margin: 0 0 12px; font-weight: 700; line-height: 1.35; }\n.cert-card p, .problem-card p { color: var(--gt-text) !important; font-size: 15px !important; line-height: 1.7 !important; margin: 0 !important; }\n.cert-card strong, .problem-card strong { color: var(--gt-primary-dark); }\n.doc-list { list-style: none !important; padding-left: 0 !important; counter-reset: doc; }\n.doc-list li {\n  background: #fff;\n  border: 1px solid var(--gt-border);\n  border-left: 4px solid var(--gt-primary);\n  border-radius: 10px;\n  padding: 18px 22px 18px 70px;\n  margin-bottom: 12px !important;\n  position: relative;\n  font-size: 16px !important;\n  line-height: 1.6 !important;\n  counter-increment: doc;\n  transition: all 0.2s;\n}\n.doc-list li:hover { box-shadow: 0 6px 24px rgba(7,166,152,0.1); transform: translateX(4px); }\n.doc-list li:before {\n  content: counter(doc, decimal-leading-zero);\n  position: absolute;\n  left: 18px; top: 50%; transform: translateY(-50%);\n  background: linear-gradient(135deg, var(--gt-primary), var(--gt-primary-dark));\n  color: #fff;\n  width: 36px; height: 36px;\n  border-radius: 50%;\n  display: flex; align-items: center; justify-content: center;\n  font-weight: 700; font-size: 13px;\n}\n.cases-grid { display: grid; grid-template-columns: repeat(auto-fit, minmax(310px, 1fr)); gap: 24px; margin: 40px 0; }\n.case-card {\n  background: linear-gradient(180deg, #fff 0%, #f7fafa 100%);\n  border-radius: 14px;\n  padding: 30px 28px 28px;\n  border-top: 4px solid var(--gt-primary);\n  box-shadow: 0 6px 24px rgba(14,18,29,0.06);\n  position: relative;\n  transition: all 0.25s;\n}\n.case-card:hover { transform: translateY(-4px); box-shadow: 0 16px 40px rgba(7,166,152,0.15); }\n.case-card .case-badge { display: inline-block; background: var(--gt-heading); color: #fff; padding: 5px 12px; border-radius: 50px; font-size: 11px; font-weight: 700; letter-spacing: 1px; text-transform: uppercase; margin-bottom: 14px; }\n.case-card .case-num { position: absolute; top: 20px; right: 24px; font-size: 56px; font-weight: 800; color: var(--gt-primary); opacity: 0.16; line-height: 1; font-family: Outfit, sans-serif; }\n.case-card h4 { color: var(--gt-heading) !important; font-size: 18px; font-weight: 700; margin: 0 0 12px; line-height: 1.35; }\n.case-card p { color: var(--gt-text) !important; font-size: 15px !important; line-height: 1.65 !important; margin: 0 0 16px !important; }\n.case-card .case-meta { display: flex; gap: 14px; flex-wrap: wrap; padding-top: 14px; border-top: 1px dashed var(--gt-border); }\n.case-card .case-tag { display: inline-flex; align-items: center; gap: 6px; font-size: 12px; color: var(--gt-text-soft); font-weight: 600; }\n.case-card .case-tag i { color: var(--gt-primary); font-size: 13px; }\n.why-grid { display: grid; grid-template-columns: repeat(auto-fit, minmax(320px, 1fr)); gap: 18px; margin: 40px 0; }\n.why-grid .why-item {\n  display: flex;\n  gap: 16px;\n  padding: 22px 24px;\n  background: #fff;\n  border-radius: 12px;\n  border: 1px solid var(--gt-border);\n  transition: all 0.2s;\n}\n.why-grid .why-item:hover { border-color: var(--gt-primary); box-shadow: 0 8px 24px rgba(7,166,152,0.1); }\n.why-grid .why-icon {\n  flex: 0 0 46px; width: 46px; height: 46px;\n  background: rgba(7,166,152,0.1); color: var(--gt-primary);\n  border-radius: 12px;\n  display: flex; align-items: center; justify-content: center;\n  font-size: 20px;\n}\n.why-grid .why-text strong { display: block; color: var(--gt-heading); font-size: 16px; margin-bottom: 4px; }\n.why-grid .why-text p { color: var(--gt-text); font-size: 14px !important; line-height: 1.6 !important; margin: 0 !important; }\n.faq { margin: 30px 0; }\n.faq details {\n  background: #fff;\n  border: 1px solid var(--gt-border);\n  padding: 0;\n  border-radius: 12px;\n  margin-bottom: 12px;\n  cursor: pointer;\n  transition: all 0.2s;\n  overflow: hidden;\n}\n.faq details:hover { border-color: var(--gt-primary); }\n.faq summary {\n  list-style: none;\n  padding: 22px 60px 22px 26px;\n  font-weight: 600;\n  color: var(--gt-heading);\n  font-size: 16px;\n  position: relative;\n  outline: none;\n  transition: color 0.2s;\n}\n.faq summary::-webkit-details-marker { display: none; }\n.faq summary:after {\n  content: \"+\";\n  position: absolute;\n  right: 24px; top: 50%; transform: translateY(-50%);\n  width: 32px; height: 32px;\n  background: rgba(7,166,152,0.1);\n  color: var(--gt-primary);\n  border-radius: 50%;\n  display: flex; align-items: center; justify-content: center;\n  font-size: 22px; font-weight: 400;\n  transition: all 0.25s;\n}\n.faq details[open] { border-color: var(--gt-primary); box-shadow: 0 6px 24px rgba(7,166,152,0.08); }\n.faq details[open] summary { color: var(--gt-primary-dark); padding-bottom: 8px; }\n.faq details[open] summary:after { content: \"\\\\2013\"; background: var(--gt-primary); color: #fff; transform: translateY(-50%) rotate(180deg); }\n.faq details p { color: var(--gt-text); padding: 0 26px 22px; margin: 0; line-height: 1.75; font-size: 15px; }\n.highlight-box {\n  background: linear-gradient(135deg, rgba(7,166,152,0.06), rgba(7,166,152,0.02));\n  border-left: 4px solid var(--gt-primary);\n  padding: 22px 26px;\n  border-radius: 0 10px 10px 0;\n  margin: 28px 0;\n  font-size: 16px;\n  color: var(--gt-heading);\n  line-height: 1.7;\n}\n.highlight-box strong { color: var(--gt-primary-dark); }\n.section-divider {\n  display: flex; align-items: center; justify-content: center;\n  margin: 60px 0; gap: 12px;\n}\n.section-divider:before, .section-divider:after {\n  content: \"\"; flex: 1 1 100px; max-width: 120px; height: 1px;\n  background: linear-gradient(90deg, transparent, var(--gt-border), transparent);\n}\n.section-divider .dot { width: 8px; height: 8px; background: var(--gt-primary); border-radius: 50%; }\n.preview-banner { position: fixed; top: 0; left: 0; right: 0; background: var(--gt-accent-orange); color: #fff; text-align: center; padding: 9px 16px; font-size: 13px; font-weight: 600; z-index: 99999; font-family: Outfit, sans-serif; box-shadow: 0 2px 12px rgba(0,0,0,0.15); }\n.preview-banner a { color: #fff; text-decoration: underline; }\nbody { padding-top: 38px; }\n.header { top: 38px !important; }\n.cky-consent-container { box-shadow: 0 -2px 24px rgba(0,0,0,0.08) !important; }\n.blog-details-content .cta-box-final + * { margin-top: 0 !important; }\n.blog-details-content > *:last-child { margin-bottom: 0 !important; }\n@media (max-width: 768px) {\n  .blog-details-content h2 { font-size: 26px; margin-top: 44px; }\n  .cta-box { padding: 28px 22px; margin: 28px 0; }\n  .cta-box h3 { font-size: 21px; }\n  .cta-box p { font-size: 15px; }\n  .cta-btn { padding: 12px 22px; font-size: 14px; width: 100%; justify-content: center; margin: 4px 0; }\n  .cta-btn-outline { padding: 10px 20px; }\n  .cta-box-final { padding: 40px 22px; }\n  .cta-box-final h3 { font-size: 24px; }\n  .pull-quote { padding: 24px 22px; font-size: 18px; margin: 28px 0; }\n  .stats-bar { padding: 18px 0; margin: 18px 16px 30px; }\n  .stats-bar .stat-num { font-size: 30px; }\n  .stats-bar .stat-label { font-size: 11px; letter-spacing: 0.8px; }\n  .doc-list li { padding: 16px 18px 16px 62px; font-size: 15px !important; }\n  .case-card { padding: 24px 22px; }\n  .case-card .case-num { font-size: 44px; }\n  .why-grid .why-item { padding: 18px 20px; }\n  .cert-card, .problem-card { padding: 26px 22px; }\n  .blog-details-content > p:first-of-type { font-size: 17px; }\n  .blog-details-content > p:first-of-type:first-letter { font-size: 50px; padding: 0 10px 0 0; }\n  .info-table th, .info-table td { padding: 12px 14px; font-size: 14px; }\n  .faq summary { padding: 18px 50px 18px 20px; font-size: 15px; }\n  .faq details p { padding: 0 20px 18px; font-size: 14px; }\n  .highlight-box { padding: 18px 20px; font-size: 15px; }\n}<\/style>\n<div class=\"stats-bar\">\n    <div class=\"stat\"><span class=\"stat-num\">40<span class=\"plus\">+<\/span><\/span><span class=\"stat-label\">Years of experience<\/span><\/div>\n    <div class=\"stat\"><span class=\"stat-num\">10M<span class=\"plus\">+<\/span><\/span><span class=\"stat-label\">Words translated<\/span><\/div>\n    <div class=\"stat\"><span class=\"stat-num\">1000<span class=\"plus\">+<\/span><\/span><span class=\"stat-label\">Satisfied clients<\/span><\/div>\n    <div class=\"stat\"><span class=\"stat-num\">MDR<span class=\"plus\">\/IVDR<\/span><\/span><span class=\"stat-label\">Regulatory compliance<\/span><\/div>\n<\/div>\n<h2>Regulatory translation allows a medical device to be accepted in the market where it will be sold<\/h2>\n<p>For a medical device manufacturer, translation is not a closing communication step: it is a compliance requirement. Regulation (EU) 2017\/745 (MDR) and Regulation (EU) 2017\/746 (IVDR) require certain information to accompany the product in the official language of each Member State where it is made available. That makes translation part of the technical file \u2014 and subjects it to the same demands of traceability and control as the rest of the regulatory documentation. It is, in practice, technical translation carrying an added regulatory burden.<\/p>\n<div class=\"pull-quote\">Once language content forms part of the technical file, an inconsistent translation stops being an editorial problem and becomes a compliance deviation.<\/div>\n<p>At GT-Tradu\u00e7\u00f5es we have worked with technical and clinical documentation for four decades. We translate for manufacturers, distributors and authorised representatives, with translators native in the target language and proven practice in the sector.<\/p>\n<div class=\"cta-box cta-box-alt\"><span class=\"badge-trust\"><i class=\"fa-solid fa-handshake\"><\/i> B2B partnerships<\/span><h3>Are you placing a device in new EU markets?<\/h3><p>We review the document set and the required languages, and propose a translation circuit with glossary, version control and technical validation.<\/p><a href=\"https:\/\/gt-traducoes.pt\/en\/contact-us\/\" class=\"cta-btn\"><i class=\"fa-solid fa-phone\"><\/i> Contact our team<\/a><\/div>\n\n<h2>The documentation we translate for manufacturers<\/h2>\n<ol class=\"doc-list\">\n    <li><strong>Instructions for use (IFU) and labelling<\/strong> \u2014 the information accompanying the product, which the user or healthcare professional must understand without ambiguity.<\/li>\n    <li><strong>Clinical trial and clinical investigation documentation<\/strong> \u2014 protocols, investigator brochures, consent forms and reports.<\/li>\n    <li><strong>Post-market surveillance<\/strong> \u2014 periodic reports, incident notifications and field safety corrective actions.<\/li>\n    <li><strong>Clinical evaluation and risk management<\/strong> \u2014 documentation supporting the technical file.<\/li>\n    <li><strong>Technical and maintenance manuals<\/strong> \u2014 installation, calibration and servicing of the equipment.<\/li>\n    <li><strong>Technical training materials<\/strong> \u2014 content for professionals who use or install the device.<\/li>\n    <li><strong>Declarations and correspondence with notified bodies<\/strong> \u2014 where the certification process requires it.<\/li>\n<\/ol>\n<div class=\"highlight-box\"><strong>Important:<\/strong> the languages required and the scope of the information to be translated depend on the Member States where the device is made available and on the product&#8217;s risk class. Always confirm the applicable requirements with the notified body or the competent authority; our role is to deliver the translation with the rigour and control those requirements presuppose.<\/div>\n\n<h2>How we handle regulatory documentation<\/h2>\n<div class=\"cert-grid\">\n    <div class=\"cert-card\"><div class=\"icon-wrap\"><i class=\"fa-solid fa-book-open\"><\/i><\/div><h3>Manufacturer-approved glossary<\/h3><p>We fix the product terminology before translating and submit it for approval. The glossary is what ensures the same component is named the same way across every language and every version.<\/p><\/div>\n    <div class=\"cert-card\"><div class=\"icon-wrap\"><i class=\"fa-solid fa-code-branch\"><\/i><\/div><h3>Version control<\/h3><p>Each revision of the source document produces a traceable update in the target languages. When the original changes, we know precisely what must be retranslated and what stands.<\/p><\/div>\n    <div class=\"cert-card\"><div class=\"icon-wrap\"><i class=\"fa-solid fa-user-check\"><\/i><\/div><h3>Technical validation<\/h3><p>Revision is carried out by a second professional with domain knowledge, and the manufacturer may bring its own in-country reviewer into the circuit before final approval.<\/p><\/div>\n<\/div>\n<div class=\"cta-box\"><span class=\"badge-trust\"><i class=\"fa-solid fa-shield-check\"><\/i> Reply in &lt;4 working hours<\/span><h3>Need consistency across languages and across versions?<\/h3><p>We establish the glossary, the review circuit and the version history before work begins \u2014 so the documentation can grow without losing coherence.<\/p><a href=\"https:\/\/gt-traducoes.pt\/traducao\/#orcamento\" class=\"cta-btn\"><i class=\"fa-solid fa-file-lines\"><\/i> Request a quote<\/a><a href=\"https:\/\/wa.me\/351934602625?text=Hello%2C%20we%20are%20a%20medical%20device%20manufacturer\" class=\"cta-btn cta-btn-outline\"><i class=\"fa-brands fa-whatsapp\"><\/i> WhatsApp<\/a><\/div>\n\n<h2>The types of project we handle<\/h2>\n<div class=\"cases-grid\">\n    <div class=\"case-card\"><span class=\"case-num\">01<\/span><span class=\"case-badge\"><i class=\"fa-solid fa-language\"><\/i> EN \u2192 PT<\/span><h4>IFU and labelling for the Portuguese market<\/h4><p>Instructions for use and labelling for an imported device, with terminology aligned to the technical documentation already in place.<\/p><div class=\"case-meta\"><span class=\"case-tag\">IFU<\/span><span class=\"case-tag\">MDR<\/span><\/div><\/div>\n    <div class=\"case-card\"><span class=\"case-num\">02<\/span><span class=\"case-badge\"><i class=\"fa-solid fa-language\"><\/i> PT \u2192 EN, FR, DE<\/span><h4>Clinical investigation file<\/h4><p>Protocol, consent forms and reports prepared in three languages, with a fixed glossary and version control maintained throughout the study.<\/p><div class=\"case-meta\"><span class=\"case-tag\">Trials<\/span><span class=\"case-tag\">Consent<\/span><\/div><\/div>\n    <div class=\"case-card\"><span class=\"case-num\">03<\/span><span class=\"case-badge\"><i class=\"fa-solid fa-language\"><\/i> EN \u2192 PT<\/span><h4>Post-market surveillance<\/h4><p>Incident notification and field safety corrective action, translated to short deadlines with terminology matching the technical file.<\/p><div class=\"case-meta\"><span class=\"case-tag\">Post-market<\/span><span class=\"case-tag\">Safety<\/span><\/div><\/div>\n<\/div>\n\n<h2>Why entrust it to GT-Tradu\u00e7\u00f5es<\/h2>\n<div class=\"why-grid\">\n    <div class=\"why-item\"><div class=\"why-icon\"><i class=\"fa-solid fa-clock-rotate-left\"><\/i><\/div><div class=\"why-text\"><strong>Four decades of practice<\/strong><p>Since 1986 we have translated technical and clinical documentation, from our office in Loul\u00e9.<\/p><\/div><\/div>\n    <div class=\"why-item\"><div class=\"why-icon\"><i class=\"fa-solid fa-user-gear\"><\/i><\/div><div class=\"why-text\"><strong>Technical translators from the sector<\/strong><p>Each project goes to translators with practice in medical devices, always working into their own native language.<\/p><\/div><\/div>\n    <div class=\"why-item\"><div class=\"why-icon\"><i class=\"fa-solid fa-list-check\"><\/i><\/div><div class=\"why-text\"><strong>Multi-stage quality assurance<\/strong><p>Translation, independent revision and terminology checking before delivery.<\/p><\/div><\/div>\n    <div class=\"why-item\"><div class=\"why-icon\"><i class=\"fa-solid fa-award\"><\/i><\/div><div class=\"why-text\"><strong>Members of the CIOL<\/strong><p>We are members of the Chartered Institute of Linguists, under a demanding professional code.<\/p><\/div><\/div>\n    <div class=\"why-item\"><div class=\"why-icon\"><i class=\"fa-solid fa-lock\"><\/i><\/div><div class=\"why-text\"><strong>Confidentiality and GDPR<\/strong><p>Product documentation and study data handled within a restricted circuit, under confidentiality agreements.<\/p><\/div><\/div>\n    <div class=\"why-item\"><div class=\"why-icon\"><i class=\"fa-solid fa-globe\"><\/i><\/div><div class=\"why-text\"><strong>EU market languages<\/strong><p>English, French, Spanish, German, Italian, Dutch and Polish, among other combinations.<\/p><\/div><\/div>\n<\/div>\n\n<h2>Frequently asked questions<\/h2>\n<div class=\"faq\">\n    <details><summary>What information must be translated under the MDR and the IVDR?<\/summary><p>The regulations require the information accompanying the device to be made available in the official language of each Member State where the product is placed. The exact scope depends on the risk class and the market, and should be confirmed with the notified body or the competent authority.<\/p><\/details>\n    <details><summary>How do you keep versions of the same document consistent?<\/summary><p>Through an approved glossary and version control. When the source is revised, we identify what has changed and update only those passages, leaving the remaining text stable across languages.<\/p><\/details>\n    <details><summary>Can our in-country reviewer take part in the process?<\/summary><p>Yes. We bring the manufacturer&#8217;s or distributor&#8217;s reviewer into the circuit before final approval, and incorporate their decisions into the glossary for subsequent translations.<\/p><\/details>\n    <details><summary>Does regulatory documentation require certified translation?<\/summary><p>Not always. Certification is required in specific formal procedures and before certain bodies. We confirm with you, document by document, what is required before proceeding.<\/p><\/details>\n    <details><summary>Can you meet short deadlines for post-market surveillance?<\/summary><p>Yes. For incident notifications and field safety corrective actions we agree an urgent circuit in advance, with defined turnaround times and terminology already fixed.<\/p><\/details>\n    <details><summary>Is this technical translation or certified translation?<\/summary><p>It is technical translation: regulatory documentation, instructions for use, labelling and manuals handled by professionals with practice in the sector, with an approved glossary and version control. Certification only comes into play where a formal procedure requires it, and in that case we arrange both.<\/p><\/details>\n<\/div>\n<div class=\"cta-box cta-box-final\"><span class=\"badge-trust\"><i class=\"fa-solid fa-star\"><\/i> Members of the Chartered Institute of Linguists<\/span><h3>We support your device&#8217;s multilingual documentation<\/h3><p>Tell us the document set, the required languages and the expected timeline, and we will put forward a proposal with glossary, review circuit and version control. Office in Loul\u00e9, serving the whole of the Algarve and the country.<\/p><a href=\"https:\/\/gt-traducoes.pt\/traducao\/#orcamento\" class=\"cta-btn cta-btn-large\"><i class=\"fa-solid fa-paper-plane\"><\/i> Request a quote<\/a><p class=\"cta-small\">or call <a href=\"tel:+351934602625\">+351 934 602 625<\/a> \u00b7 <a href=\"mailto:info@gt-traducoes.pt\">info@gt-traducoes.pt<\/a><\/p><\/div>\n<\/div>\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>IFU, labelling, clinical trials and post-market surveillance translated with an approved glossary, version control and technical validation, for MDR and IVDR 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