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<!DOCTYPE html> <html lang="en"> <head> <meta charset="UTF-8"> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <title>White Globe — EU MDR Documentation Services for Indian Medical Device Exporters</title> <link rel="preconnect" href="https://fonts.googleapis.com"> <link rel="preconnect" href="https://fonts.gstatic.com" crossorigin> <link href="https://fonts.googleapis.com/css2?family=DM+Serif+Display:ital@0;1&family=Inter:wght@300;400;500;600;700&display=swap" rel="stylesheet"> <style> *, *::before, *::after { box-sizing: border-box; margin: 0; padding: 0; } :root { --navy: #0D1E3E; --navy2: #162D57; --teal: #0B9E73; --teal2: #089062; --teal-lt: #E6F7F2; --slate: #4A5568; --muted: #718096; --border: #E2E8F0; --bg: #F7F8FA; --white: #FFFFFF; --red: #C53030; --amber: #B7791F; } html { scroll-behavior: smooth; } body { font-family: 'Inter', system-ui, sans-serif; font-size: 16px; line-height: 1.6; color: var(--navy); background: var(--white); -webkit-font-smoothing: antialiased; } /* ── NAV ── */ /* ── HERO ── */ .hero { background: var(--navy); padding: clamp(3rem, 8vw, 6rem) clamp(1.5rem, 5vw, 4rem) 0; overflow: hidden; position: relative; } .hero-grid { max-width: 1120px; margin: 0 auto; display: grid; grid-template-columns: 1fr 1fr; gap: 4rem; align-items: start; } @media (max-width: 768px) { .hero-grid { grid-template-columns: 1fr; gap: 2.5rem; } } .hero-eyebrow { font-size: 11px; font-weight: 600; letter-spacing: 0.14em; text-transform: uppercase; color: var(--teal); margin-bottom: 1.2rem; display: flex; align-items: center; gap: 8px; } .hero-eyebrow::before { content: ''; display: inline-block; width: 24px; height: 2px; background: var(--teal); } .hero h1 { font-family: 'DM Serif Display', Georgia, serif; font-size: clamp(2rem, 4.5vw, 3.4rem); font-weight: 400; line-height: 1.15; color: var(--white); margin-bottom: 1.5rem; } .hero h1 em { font-style: italic; color: var(--teal); } .hero-sub { font-size: 16px; color: #A0AEC0; line-height: 1.7; margin-bottom: 2rem; max-width: 480px; } .hero-actions { display: flex; gap: 12px; flex-wrap: wrap; } .btn-primary { background: var(--teal); color: var(--white); padding: 13px 24px; border-radius: 4px; font-size: 14px; font-weight: 600; text-decoration: none; border: none; cursor: pointer; transition: background 0.15s; display: inline-block; } .btn-primary:hover { background: var(--teal2); } .btn-ghost { background: transparent; color: var(--white); padding: 13px 24px; border-radius: 4px; font-size: 14px; font-weight: 500; text-decoration: none; border: 1px solid rgba(255,255,255,0.25); cursor: pointer; transition: border-color 0.15s, color 0.15s; display: inline-block; } .btn-ghost:hover { border-color: var(--teal); color: var(--teal); } /* ── COUNTDOWN ── */ .countdown-card { background: rgba(255,255,255,0.05); border: 1px solid rgba(255,255,255,0.12); border-radius: 8px; padding: 2rem; backdrop-filter: blur(8px); } .countdown-title { font-size: 11px; font-weight: 600; letter-spacing: 0.12em; text-transform: uppercase; color: var(--teal); margin-bottom: 0.4rem; } .countdown-label { font-size: 13px; color: #A0AEC0; margin-bottom: 1.6rem; line-height: 1.4; } .dl-big-rows { display: flex; flex-direction: column; gap: 10px; } .dl-big { display: flex; gap: 14px; align-items: flex-start; padding: 14px 16px; border-radius: 7px; } .dl-critical { background: rgba(197,48,48,0.15); border: 1px solid rgba(197,48,48,0.35); } .dl-warning { background: rgba(183,121,31,0.15); border: 1px solid rgba(236,201,75,0.35); } .dl-passed { background: rgba(11,158,115,0.12); border: 1px solid rgba(11,158,115,0.3); } .dl-big-left { text-align: center; min-width: 72px; flex-shrink: 0; padding-top: 2px; } .dl-big-num { font-size: 2.2rem; font-weight: 800; line-height: 1; font-variant-numeric: tabular-nums; color: var(--white); } .dl-big.critical .dl-big-num { color: #FC8181; } .dl-big.warning .dl-big-num { color: #ECC94B; } .dl-big.passed .dl-big-num { color: #68D391; } .dl-big-unit { font-size: 9px; text-transform: uppercase; letter-spacing: 0.1em; color: #718096; margin-top: 3px; font-weight: 600; } .dl-big-right { flex: 1; } .dl-big-class { font-size: 13px; font-weight: 700; color: var(--white); margin-bottom: 2px; } .dl-big-ref { font-size: 11px; color: #A0AEC0; margin-bottom: 5px; } .dl-big-note { font-size: 11px; color: #718096; line-height: 1.45; font-style: italic; } /* ── HERO BOTTOM WAVE ── */ .hero-bottom { height: 60px; margin-top: 4rem; background: var(--navy); clip-path: ellipse(60% 100% at 50% 100%); } /* ── CREDENTIAL BAR ── */ .cred-bar { background: var(--white); border-bottom: 1px solid var(--border); padding: 0 clamp(1.5rem, 5vw, 4rem); } .cred-inner { max-width: 1120px; margin: 0 auto; display: flex; align-items: center; gap: 0; overflow-x: auto; -webkit-overflow-scrolling: touch; } .cred-item { display: flex; align-items: center; gap: 8px; padding: 14px 20px; white-space: nowrap; border-right: 1px solid var(--border); flex-shrink: 0; } .cred-item:last-child { border-right: none; } .cred-icon { font-size: 16px; } .cred-text { font-size: 12px; font-weight: 600; color: var(--slate); } .cred-text span { color: var(--teal); } /* ── SECTION WRAPPER ── */ .section { padding: clamp(3rem, 6vw, 5rem) clamp(1.5rem, 5vw, 4rem); } .inner { max-width: 1120px; margin: 0 auto; } .section-eye { font-size: 11px; font-weight: 600; letter-spacing: 0.14em; text-transform: uppercase; color: var(--teal); margin-bottom: 0.75rem; display: flex; align-items: center; gap: 8px; } .section-eye::before { content: ''; display: inline-block; width: 20px; height: 2px; background: var(--teal); } .section-h { font-family: 'DM Serif Display', Georgia, serif; font-size: clamp(1.6rem, 3vw, 2.4rem); font-weight: 400; line-height: 1.2; color: var(--navy); margin-bottom: 0.75rem; } .section-sub { font-size: 15px; color: var(--slate); max-width: 600px; line-height: 1.7; } .section-header { margin-bottom: 3rem; } /* ── PROBLEM SECTION ── */ .problem { background: var(--bg); } .problem-grid { display: grid; grid-template-columns: 1fr 1fr; gap: 2rem; margin-top: 2.5rem; } @media (max-width: 640px) { .problem-grid { grid-template-columns: 1fr; } } .problem-card { background: var(--white); border: 1px solid var(--border); border-radius: 8px; padding: 1.5rem; border-left: 3px solid var(--teal); } .problem-card h3 { font-size: 14px; font-weight: 700; color: var(--navy); margin-bottom: 0.5rem; } .problem-card p { font-size: 13px; color: var(--slate); line-height: 1.6; } /* ── WHO WE SERVE ── */ .prospects-grid { display: grid; grid-template-columns: repeat(auto-fit, minmax(200px, 1fr)); gap: 1rem; margin-top: 2.5rem; } .prospect-pill { display: flex; align-items: center; gap: 10px; background: var(--white); border: 1px solid var(--border); border-radius: 6px; padding: 12px 14px; font-size: 13px; font-weight: 500; color: var(--navy); } .prospect-dot { width: 8px; height: 8px; border-radius: 50%; background: var(--teal); flex-shrink: 0; } /* ── SERVICES ── */ .services { background: var(--navy); } .services .section-eye { color: var(--teal); } .services .section-h { color: var(--white); } .services .section-sub { color: #A0AEC0; } .services-grid { display: grid; grid-template-columns: repeat(auto-fit, minmax(280px, 1fr)); gap: 1px; background: rgba(255,255,255,0.08); border: 1px solid rgba(255,255,255,0.08); border-radius: 10px; overflow: hidden; } .service-card { background: var(--navy2); padding: 1.75rem; transition: background 0.15s; } .service-card:hover { background: rgba(11,158,115,0.08); } .service-num { font-size: 11px; font-weight: 700; letter-spacing: 0.12em; color: var(--teal); text-transform: uppercase; margin-bottom: 0.75rem; } .service-card h3 { font-size: 15px; font-weight: 600; color: var(--white); margin-bottom: 0.5rem; line-height: 1.3; } .service-card p { font-size: 13px; color: #A0AEC0; line-height: 1.6; } .service-tags { display: flex; flex-wrap: wrap; gap: 6px; margin-top: 1rem; } .stag { font-size: 10px; font-weight: 600; letter-spacing: 0.06em; background: rgba(11,158,115,0.15); color: var(--teal); padding: 3px 9px; border-radius: 20px; text-transform: uppercase; } /* ── WHY WHITE GLOBE ── */ .why { background: var(--white); } .iso-grid { display: grid; grid-template-columns: repeat(auto-fit, minmax(240px, 1fr)); gap: 1rem; margin-top: 2.5rem; } .iso-card { border: 1px solid var(--border); border-radius: 8px; padding: 1.25rem 1.5rem; display: flex; gap: 12px; align-items: flex-start; } .iso-badge { background: var(--teal-lt); color: var(--teal); font-size: 10px; font-weight: 700; letter-spacing: 0.05em; padding: 4px 8px; border-radius: 4px; white-space: nowrap; flex-shrink: 0; margin-top: 2px; } .iso-text h4 { font-size: 13px; font-weight: 600; color: var(--navy); margin-bottom: 3px; } .iso-text p { font-size: 12px; color: var(--muted); line-height: 1.5; } /* ── PROCESS ── */ .process { background: var(--bg); } .process-strip { display: grid; grid-template-columns: repeat(7, 1fr); gap: 0; margin-top: 2.5rem; border: 1px solid var(--border); border-radius: 8px; overflow: hidden; } @media (max-width: 900px) { .process-strip { grid-template-columns: 1fr; } .process-arrow { display: none; } } .process-step { padding: 1.5rem 1.25rem; background: var(--white); border-right: 1px solid var(--border); position: relative; text-align: center; } .process-step:last-child { border-right: none; } .process-step:hover { background: var(--teal-lt); } .ps-num { display: inline-block; width: 28px; height: 28px; border-radius: 50%; background: var(--navy); color: var(--white); font-size: 12px; font-weight: 700; line-height: 28px; text-align: center; margin-bottom: 0.75rem; } .ps-title { font-size: 12px; font-weight: 700; color: var(--navy); margin-bottom: 0.4rem; } .ps-desc { font-size: 11px; color: var(--muted); line-height: 1.5; } /* ── PRICING ── */ .pricing-table { width: 100%; border-collapse: collapse; margin-top: 2rem; border: 1px solid var(--border); border-radius: 8px; overflow: hidden; font-size: 14px; } .pricing-table th { background: var(--navy); color: var(--white); padding: 12px 16px; text-align: left; font-size: 12px; font-weight: 600; letter-spacing: 0.05em; } .pricing-table td { padding: 12px 16px; border-bottom: 1px solid var(--border); color: var(--slate); } .pricing-table tr:last-child td { border-bottom: none; } .pricing-table tr:nth-child(even) td { background: var(--bg); } .price-val { color: var(--teal); font-weight: 600; } .pricing-note { font-size: 12px; color: var(--muted); margin-top: 1rem; font-style: italic; } /* ── CTA ── */ .cta-section { background: var(--navy); padding: clamp(4rem, 8vw, 7rem) clamp(1.5rem, 5vw, 4rem); text-align: center; } .cta-section h2 { font-family: 'DM Serif Display', Georgia, serif; font-size: clamp(1.75rem, 3.5vw, 3rem); font-weight: 400; color: var(--white); margin-bottom: 1rem; } .cta-section h2 em { color: var(--teal); font-style: italic; } .cta-section p { font-size: 15px; color: #A0AEC0; margin-bottom: 2.5rem; max-width: 520px; margin-left: auto; margin-right: auto; } .cta-buttons { display: flex; gap: 12px; justify-content: center; flex-wrap: wrap; } .btn-lg { padding: 15px 32px; border-radius: 4px; font-size: 15px; font-weight: 600; text-decoration: none; display: inline-block; transition: 0.15s; cursor: pointer; border: none; } .btn-lg.primary { background: var(--teal); color: var(--white); } .btn-lg.primary:hover { background: var(--teal2); } .btn-lg.outline { background: transparent; color: var(--white); border: 1px solid rgba(255,255,255,0.3); } .btn-lg.outline:hover { border-color: var(--teal); color: var(--teal); } .contact-cards { display: grid; grid-template-columns: repeat(auto-fit, minmax(220px, 1fr)); gap: 1rem; margin-top: 3rem; max-width: 700px; margin-left: auto; margin-right: auto; } .contact-card { background: rgba(255,255,255,0.06); border: 1px solid rgba(255,255,255,0.12); border-radius: 8px; padding: 1.25rem; text-align: left; } .contact-card-lbl { font-size: 10px; font-weight: 600; letter-spacing: 0.1em; text-transform: uppercase; color: var(--teal); margin-bottom: 4px; } .contact-card-val { font-size: 14px; color: var(--white); font-weight: 500; word-break: break-all; } /* ── FOOTER ── */ footer { background: #080F1E; padding: 1.5rem clamp(1.5rem, 5vw, 4rem); display: flex; align-items: center; justify-content: space-between; flex-wrap: wrap; gap: 1rem; } .footer-brand { font-size: 13px; font-weight: 700; color: rgba(255,255,255,0.5); letter-spacing: 0.08em; text-transform: uppercase; } .footer-brand span { color: var(--teal); } .footer-cert { display: flex; gap: 10px; flex-wrap: wrap; } .fcert { font-size: 10px; color: rgba(255,255,255,0.3); font-weight: 500; } /* ── STAT STRIP ── */ .stat-strip { background: var(--teal); padding: 1.25rem clamp(1.5rem, 5vw, 4rem); } .stat-inner { max-width: 1120px; margin: 0 auto; display: flex; gap: 2rem; flex-wrap: wrap; justify-content: space-between; } .stat-item { text-align: center; } .stat-num { font-size: clamp(1.5rem, 3vw, 2.2rem); font-weight: 800; color: var(--white); line-height: 1; } .stat-desc { font-size: 11px; color: rgba(255,255,255,0.85); font-weight: 500; margin-top: 3px; } @media (prefers-reduced-motion: reduce) { *, *::before, *::after { animation: none !important; 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</a> </li> </ul> </div> </nav> <!-- HERO --> <section class="hero"> <div class="hero-grid inner" style="padding-bottom: 3rem;"> <div> <p class="hero-eyebrow">EU MDR Transition Services for Indian MedTech Exporters</p> <h1>Your CE marks expire.<br>Your <em>documentation</em><br>must not.</h1> <p class="hero-sub">White Globe delivers ISO 13485-certified IFU localisation, SSCP translation, and technical file documentation across all 24 EU official languages — built specifically for Indian medical device manufacturers.</p> <div class="hero-actions"> <a href="#contact" class="btn-primary">Request a Quote</a> <a href="#services" class="btn-ghost">View Services</a> </div> </div> <!-- DEADLINE TRACKER --> <div class="countdown-card"> <p class="countdown-title">EU MDR Transition Deadline Tracker</p> <p class="countdown-label">Days remaining as of today — recalculated every time this page opens</p> <div class="dl-big-rows"> <div class="dl-big dl-critical"> <div class="dl-big-left"> <div class="dl-big-num dl-num-red" id="days-2027">—</div> <div class="dl-big-unit">days left</div> </div> <div class="dl-big-right"> <div class="dl-big-class">Class IIb implantable devices</div> <div class="dl-big-ref">EU MDR Art. 120 · Deadline: 31 Dec 2027</div> <div class="dl-big-note">Highest urgency — documentation must reach Notified Body well before this date</div> </div> </div> <div class="dl-big dl-warning"> <div class="dl-big-left"> <div class="dl-big-num dl-num-amber" id="days-2028">—</div> <div class="dl-big-unit">days left</div> </div> <div class="dl-big-right"> <div class="dl-big-class">Class IIb, IIa & eligible Class I</div> <div class="dl-big-ref">EU MDR Art. 120 · Deadline: 31 Dec 2028</div> <div class="dl-big-note">Plan your documentation programme now — Notified Body queues are already long</div> </div> </div> <div class="dl-big dl-passed"> <div class="dl-big-left"> <div class="dl-big-num dl-num-green" style="font-size:0.9rem; line-height:1.3; padding-top:4px;">Already<br>passed</div> <div class="dl-big-unit">May 2024</div> </div> <div class="dl-big-right"> <div class="dl-big-class">EU MDR fully applicable</div> <div class="dl-big-ref">MDD/AIMDD no longer valid from 26 May 2024</div> <div class="dl-big-note">All new CE marks must now be issued under MDR — no exceptions</div> </div> </div> </div> </div></div> </div> </div> </section> <!-- STAT STRIP --> <div class="stat-strip"> <div class="stat-inner"> <div class="stat-item"><div class="stat-num">#1</div><div class="stat-desc">Language Services Provider in India (Slator LSPI)</div></div> <div class="stat-item"><div class="stat-num">5×</div><div class="stat-desc">ISO Certified including ISO 13485 Medical Device</div></div> <div class="stat-item"><div class="stat-num">24</div><div class="stat-desc">Official EU Languages covered</div></div> <div class="stat-item"><div class="stat-num">350+</div><div class="stat-desc">Total languages, 100,000+ specialist linguists</div></div> <div class="stat-item"><div class="stat-num">2,750+</div><div class="stat-desc">Enterprise clients globally</div></div> </div> </div> <!-- CRED BAR --> <div class="cred-bar"> <div class="cred-inner"> <div class="cred-item"><span class="cred-text"><span>ISO 13485</span> Medical Device Docs</span></div> <div class="cred-item"><span class="cred-text"><span>ISO 17100</span> Translation Services</span></div> <div class="cred-item"><span class="cred-text"><span>ISO 27001</span> Information Security</span></div> <div class="cred-item"><span class="cred-text"><span>ISO 9001</span> Quality Management</span></div> <div class="cred-item"><span class="cred-text"><span>ISO 18587</span> MT Post-Editing</span></div> <div class="cred-item"><span class="cred-text">Slator LSPI <span>India #1 · Asia #8 · Global #89</span></span></div> </div> </div> <!-- PROBLEM SECTION --> <section class="section problem"> <div class="inner"> <div class="section-header"> <p class="section-eye">The Challenge</p> <h2 class="section-h">What the EU MDR transition means for Indian exporters</h2> <p class="section-sub">Every CE-marked device sold in Europe must now comply with EU MDR 2017/745 — and language is where most Indian manufacturers are underprepared.</p> </div> <div class="problem-grid"> <div class="problem-card"> <h3>Mandatory multilingual IFUs</h3> <p>EU MDR Article 41 and Annex I Section 23 require all Instructions for Use to be available in the official language(s) of every EU member state where the device is sold. A single product distributed across 10 countries may require 12+ language versions.</p> </div> <div class="problem-card"> <h3>SSCP is a new requirement</h3> <p>The Summary of Safety and Clinical Performance (SSCP) is mandated for Class III and implantable devices under EU MDR Article 32. It must be available in all relevant EU languages and validated by the Notified Body.</p> </div> <div class="problem-card"> <h3>Technical file localisation</h3> <p>Device Master Files, Risk Management Reports, and Clinical Evaluation Reports may need to be submitted or accessible in the working languages of Notified Bodies — typically German, French, or English depending on the NB.</p> </div> <div class="problem-card"> <h3>Living document obligations</h3> <p>MDR requires post-market surveillance reports (PSUR), periodic updates to IFUs, and vigilance reports — all of which require ongoing multilingual updates throughout the product lifecycle, not a one-time translation.</p> </div> </div> </div> </section> <!-- WHO WE SERVE --> <section class="section why" id="who"> <div class="inner"> <div class="section-header"> <p class="section-eye">Who We Serve</p> <h2 class="section-h">Indian medical device manufacturers selling in Europe</h2> <p class="section-sub">We work with Regulatory Affairs, Quality, and International Business teams at India's leading MedTech companies.</p> </div> <div class="prospects-grid"> <div class="prospect-pill"><div class="prospect-dot"></div>Cardiovascular & Stent Manufacturers</div> <div class="prospect-pill"><div class="prospect-dot"></div>Surgical Robotics & SaMD Companies</div> <div class="prospect-pill"><div class="prospect-dot"></div>Disposable Consumables Exporters</div> <div class="prospect-pill"><div class="prospect-dot"></div>Orthopaedic Implant Manufacturers</div> <div class="prospect-pill"><div class="prospect-dot"></div>IVD & Diagnostics Companies</div> <div class="prospect-pill"><div class="prospect-dot"></div>Patient Monitoring & Imaging OEMs</div> <div class="prospect-pill"><div class="prospect-dot"></div>Blood Management & Infusion Therapy</div> <div class="prospect-pill"><div class="prospect-dot"></div>ENT & Surgical Instruments</div> </div> </div> </section> <!-- SERVICES --> <section class="section services" id="services"> <div class="inner"> <div class="section-header"> <p class="section-eye">Our Services</p> <h2 class="section-h">Every document EU MDR requires, in every language it demands</h2> <p class="section-sub">Delivered by ISO 13485-certified specialists — not generalist translators.</p> </div> <div class="services-grid"> <div class="service-card"> <p class="service-num">Core Requirement</p> <h3>IFU & DFU Localisation</h3> <p>Instructions for Use and Directions for Use translated, edited, proofread, and formatted into up to 24 EU languages — with regulatory symbol preservation and DTP.</p> <div class="service-tags"><span class="stag">Annex I §23</span><span class="stag">Article 41</span><span class="stag">24 Languages</span></div> </div> <div class="service-card"> <p class="service-num">New MDR Requirement</p> <h3>SSCP Translation</h3> <p>Summary of Safety and Clinical Performance localisation per MDCG 2019-9 guidance — with separate lay-person and healthcare professional sections in each required language.</p> <div class="service-tags"><span class="stag">Article 32</span><span class="stag">Annex II</span><span class="stag">MDCG 2019-9</span></div> </div> <div class="service-card"> <p class="service-num">Label Compliance</p> <h3>Device Label & Packaging</h3> <p>Multilingual label text, packaging inserts, and carton content aligned to EU MDR Article 23 requirements — including UDI label content creation.</p> <div class="service-tags"><span class="stag">Article 23</span><span class="stag">UDI</span><span class="stag">DTP Ready</span></div> </div> <div class="service-card"> <p class="service-num">Technical Documentation</p> <h3>Technical File & DMF</h3> <p>Device Master File, Plant Master File, and Risk Management Report translation for Notified Body submission — with ISO 14971 alignment.</p> <div class="service-tags"><span class="stag">Annex II</span><span class="stag">Annex III</span><span class="stag">ISO 14971</span></div> </div> <div class="service-card"> <p class="service-num">Clinical Documentation</p> <h3>CER & Clinical Data</h3> <p>Clinical Evaluation Reports, clinical investigation documents, and back-translation for data validation — handled by specialist medical translators.</p> <div class="service-tags"><span class="stag">Annex XIV</span><span class="stag">Back-translation</span></div> </div> <div class="service-card"> <p class="service-num">Post-Market</p> <h3>PMS & PSUR Reports</h3> <p>Periodic Safety Update Reports and Post-Market Surveillance reports — translated on an ongoing basis to meet MDR's lifecycle documentation obligations.</p> <div class="service-tags"><span class="stag">Article 83–86</span><span class="stag">Ongoing</span></div> </div> <div class="service-card"> <p class="service-num">Digital & Software</p> <h3>UI String & SaMD Localisation</h3> <p>Software as a Medical Device interface localisation — screen labels, error messages, and GUI text — per CDSCO Oct 2025 draft guidance and EU MDR SaMD requirements.</p> <div class="service-tags"><span class="stag">SaMD / SiMD</span><span class="stag">CDSCO 2025</span></div> </div> <div class="service-card"> <p class="service-num">Lifecycle Management</p> <h3>Translation Memory & TMS</h3> <p>All work is stored in your dedicated Translation Memory on our Lang Tech platform — reducing costs by 30–60% on every subsequent update, version, or new market.</p> <div class="service-tags"><span class="stag">30–60% Savings</span><span class="stag">Audit Trail</span></div> </div> </div> </div> </section> <!-- PROCESS --> <section class="section process" id="process"> <div class="inner"> <div class="section-header"> <p class="section-eye">How It Works</p> <h2 class="section-h">From CE-marked portfolio to MDR-compliant documentation</h2> <p class="section-sub">A structured, repeatable programme — not a one-time project.</p> </div> <div class="process-strip"> <div class="process-step"> <div class="ps-num">1</div> <div class="ps-title">Regulatory Scoping</div> <div class="ps-desc">Portfolio review, EU market coverage, and MDR Annex gap analysis</div> </div> <div class="process-step"> <div class="ps-num">2</div> <div class="ps-title">Document × Language Matrix</div> <div class="ps-desc">Full compliance map: which documents, which languages, which member states</div> </div> <div class="process-step"> <div class="ps-num">3</div> <div class="ps-title">Glossary & TM Setup</div> <div class="ps-desc">Device-specific terminology glossary built; existing translations loaded into TM</div> </div> <div class="process-step"> <div class="ps-num">4</div> <div class="ps-title">TEP Workflow</div> <div class="ps-desc">Translation → Expert Edit → Proofreading, all by domain-specialist linguists</div> </div> <div class="process-step"> <div class="ps-num">5</div> <div class="ps-title">DTP & Formatting</div> <div class="ps-desc">All regulatory symbols, layout, and file formats preserved</div> </div> <div class="process-step"> <div class="ps-num">6</div> <div class="ps-title">QA & Delivery</div> <div class="ps-desc">ISO 13485-aligned quality check, audit trail, delivery via Lang Tech portal</div> </div> <div class="process-step"> <div class="ps-num">7</div> <div class="ps-title">Lifecycle Updates</div> <div class="ps-desc">All future versions managed incrementally via Translation Memory</div> </div> </div> </div> </section> <!-- ISO CREDENTIALS --> <section class="section why" id="why"> <div class="inner"> <div class="section-header"> <p class="section-eye">Our Credentials</p> <h2 class="section-h">The only Indian LSP with ISO 13485 for medical device documentation</h2> <p class="section-sub">Quintuple ISO certification means every part of your documentation programme — translation, quality, security, and AI oversight — is governed by an independently audited standard.</p> </div> <div class="iso-grid"> <div class="iso-card"><div class="iso-badge">ISO 13485</div><div class="iso-text"><h4>Medical Device Documentation</h4><p>Quality system specifically for medical device documentation processes — directly maps to EU MDR technical file requirements</p></div></div> <div class="iso-card"><div class="iso-badge">ISO 17100</div><div class="iso-text"><h4>Translation Services</h4><p>The international standard for translation quality — mandates TEP workflow with qualified translators and independent review</p></div></div> <div class="iso-card"><div class="iso-badge">ISO 27001</div><div class="iso-text"><h4>Information Security</h4><p>Protects your confidential technical files, clinical data, and proprietary device specifications during the translation process</p></div></div> <div class="iso-card"><div class="iso-badge">ISO 9001</div><div class="iso-text"><h4>Quality Management</h4><p>End-to-end quality management across all project types — from scoping to delivery to lifecycle updates</p></div></div> <div class="iso-card"><div class="iso-badge">ISO 18587</div><div class="iso-text"><h4>AI Translation Governance</h4><p>Governs AI-assisted translation with mandatory human post-editing — ensuring speed without compromising regulatory accuracy</p></div></div> <div class="iso-card" style="border-left: 3px solid var(--teal);"> <div class="iso-text"> <h4 style="color: var(--teal); margin-bottom: 8px;">Slator LSPI Rankings</h4> <p>India #1 · Asia #8 · Global #89</p> <p style="margin-top: 6px;">The Slator Language Service Provider Index is the most rigorous independent ranking of global LSPs by revenue, technology, and market capability.</p> </div> </div> </div> </div> </section> <!-- PRICING --> <section class="section problem" id="pricing"> <div class="inner"> <div class="section-header"> <p class="section-eye">Indicative Pricing</p> <h2 class="section-h">Transparent pricing, structured for regulated content</h2> <p class="section-sub">Formal quotes issued after document review. Volume pricing and dedicated programme rates available for multi-product engagements.</p> </div> <table class="pricing-table"> <thead> <tr><th>Service</th><th>Indicative Rate</th></tr> </thead> <tbody> <tr><td>Standard IFU / Label translation (EN → major EU language)</td><td class="price-val">₹2.40 – ₹3.30 per source word</td></tr> <tr><td>Regulated technical document (TEP + QA + ISO 13485 sign-off)</td><td class="price-val">₹3.90 – ₹4.80 per source word</td></tr> <tr><td>SSCP translation per language</td><td class="price-val">₹42,000 – ₹87,000 per language</td></tr> <tr><td>DTP / multilingual layout (per page)</td><td class="price-val">₹500 – ₹1,500 per page</td></tr> <tr><td>Translation Memory savings on repeat / updated content</td><td class="price-val">30–60% cost reduction</td></tr> <tr><td>24-language EU pack (IFU + Label)</td><td class="price-val">Custom volume quotation</td></tr> </tbody> </table> <p class="pricing-note">All pricing is indicative and subject to volume, turnaround, language pair complexity, and document type. A detailed quote is provided within 24 hours of document receipt.</p> </div> </section> <!-- CTA --> <section class="cta-section" id="contact"> <div class="inner" style="text-align:center"> <p class="section-eye" style="justify-content: center; color: var(--teal);">Get Started</p> <h2>Ready to begin your <em>MDR documentation</em> programme?</h2> <p>Share your product list and target EU markets. We will respond with a scoping proposal and indicative quote within 24 hours.</p> <div class="cta-buttons"> <a href="mailto:sales@whiteglobe.co.in?subject=EU%20MDR%20Documentation%20Enquiry&body=Hi%2C%0A%0AI%20would%20like%20to%20discuss%20EU%20MDR%20documentation%20services%20for%20our%20medical%20device%20portfolio.%0A%0ACompany%3A%0AContact%20name%3A%0AProduct%20category%3A%0ATarget%20EU%20markets%3A%0A%0APlease%20reach%20out%20to%20arrange%20a%20call." class="btn-lg primary">Email Us Now</a> <a href="https://wa.me/91XXXXXXXXXX?text=Hi%20Sudeip%2C%20I%20came%20across%20White%20Globe's%20EU%20MDR%20documentation%20services%20and%20would%20like%20to%20discuss%20our%20requirements." class="btn-lg outline" target="_blank" rel="noopener">WhatsApp</a> </div> <div class="contact-cards"> <div class="contact-card"> <div class="contact-card-lbl">Sales Enquiries</div> <div class="contact-card-val">sales@whiteglobe.co.in</div> </div> <div class="contact-card"> <div class="contact-card-lbl">Direct Contact</div> <div class="contact-card-val">preeti.saha@whiteglobe.co.in</div> </div> <div class="contact-card"> <div class="contact-card-lbl">Website</div> <div class="contact-card-val">www.whiteglobe.co.in</div> </div> <div class="contact-card"> <div class="contact-card-lbl">Headquarters</div> <div class="contact-card-val">Pune, Maharashtra, India</div> </div> </div> </div> </section> <!-- FOOTER --> <footer> <div class="footer-brand">White<span>Globe</span> — Medical Device Documentation</div> <div class="footer-cert"> <span class="fcert">ISO 13485</span><span class="fcert">·</span> <span class="fcert">ISO 17100</span><span class="fcert">·</span> <span class="fcert">ISO 27001</span><span class="fcert">·</span> <span class="fcert">ISO 9001</span><span class="fcert">·</span> <span class="fcert">ISO 18587</span><span class="fcert">·</span> <span class="fcert">Slator LSPI India #1</span> </div> </footer> <script> function daysUntil(isoDate) { const now = new Date(); const today = new Date(now.getFullYear(), now.getMonth(), now.getDate()); const target = new Date(isoDate); const diff = target - today; return Math.max(0, Math.ceil(diff / 86400000)); } function fmt(n) { return n.toLocaleString('en-IN'); } document.getElementById('days-2027').textContent = fmt(daysUntil('2027-12-31')); document.getElementById('days-2028').textContent = fmt(daysUntil('2028-12-31')); </script> </body> </html>