{"id":3109,"date":"2026-06-22T12:11:40","date_gmt":"2026-06-22T10:11:40","guid":{"rendered":"https:\/\/www.technical-center.de\/materials-expertise-medical-technology\/"},"modified":"2026-06-22T12:11:40","modified_gmt":"2026-06-22T10:11:40","slug":"materials-expertise-medical-technology","status":"publish","type":"page","link":"https:\/\/www.technical-center.de\/en\/materials-expertise-medical-technology\/","title":{"rendered":"Materials expertise for medical technology"},"content":{"rendered":"<div>\n<p>        <img decoding=\"async\" src=\"\/wp-content\/uploads\/2026\/03\/Technical-Center_Medizintechnik.jpg\" alt=\"\"><\/p>\n<h3>Materials expertise for medical technology<\/h3>\n<p>&#8211; where material failure is not an option<\/p>\n<div>\n<p><span>For manufacturers, operators and approval managers in medical technology:<br \/>Material consulting, failure analyses and fitness-for-use assessments &#8211; standard-compliant, traceable, MDR-compliant.<\/span><\/p>\n<div><span class=\"uk-label\">MDR-compliant<\/span> <span class=\"uk-label\">ISO 13485<\/span> <span class=\"uk-label\">Failure analysis<\/span> <span class=\"uk-label\">Fitness-For-Service<\/span> <span class=\"uk-label\">Material consulting<\/span> <span class=\"uk-label\">Biocompatibility<\/span> <span class=\"uk-label\">Implants &amp; instruments<\/span><\/div>\n<\/div>\n<p><a href=\"#anfrage-formular\">Submit a request now<\/a><\/p>\n<\/div>\n<div>\n<p class=\"section-label\">CHALLENGE<\/p>\n<h2 class=\"section-title\">In medical technology, material failure has immediate consequences &#8211; regulatory and clinical.<\/h2>\n<\/div>\n<ul>\n<li>\n<div>\n<ul>\n<li><span>An implant or instrument fails in service &#8211; cause and responsibility are unclear.<\/span><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li>\n<div>\n<ul>\n<li><span>Corrosion, fatigue fracture or unexpected embrittlement jeopardize product safety and market approval.<\/span><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li>\n<div>\n<ul>\n<li><span>Is a component still safe to use after an incident &#8211; or must it be recalled?<\/span><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<li>\n<div>\n<ul>\n<li><span>What caused the failure &#8211; and how do we prevent it from recurring?<\/span><\/li>\n<\/ul>\n<\/div>\n<\/li>\n<\/ul>\n<div>\n<h3>Component failure, recall or ongoing approval procedure?<\/h3>\n<div>\n<div class=\"cta-strip-left\">\n<div class=\"cta-strip-text\"><span>We analyse, document and deliver standard-compliant foundations &#8211; reachable within 24 hours.<\/span><\/div>\n<\/div>\n<\/div>\n<p><a href=\"#anfrage-formular\">Enquire directly \u2192<\/a><\/p>\n<\/div>\n<div>\n<p class=\"section-label\">SERVICES<\/p>\n<h2>Our services for medical technology<\/h2>\n<\/div>\n<div>\n<h3>Forensic failure analysis<\/h3>\n<p>01<\/p>\n<div>\n<p class=\"leist-text\">Systematic root cause investigation in component failure &#8211; implants, instruments, housings, fasteners. Fractography, metallography, EDX analysis. Standard-based documentation according to VDI 3822 for authorities, insurers and manufacturers.<\/p>\n<\/div>\n<\/div>\n<div>\n<p>    <span class=\"uk-label uk-label-success\">VDI 3822<\/span><br \/>\n  <span class=\"uk-label uk-label-success\">SEM \/ EDX<\/span><br \/>\n  <span class=\"uk-label uk-label-success\">Fractography<\/span><br \/>\n  <span class=\"uk-label uk-label-success\">MDR documentation<\/span>\n<\/div>\n<div>\n<h3>Fitness-For-Service analyses<\/h3>\n<p>02<\/p>\n<div>\n<p class=\"leist-text\">Objective assessment of the fitness-for-service of components and systems &#8211; including after incidents or changed operating conditions. Estimation of safe remaining service lives as a basis for continued-operation or recall decisions.<\/p>\n<\/div>\n<\/div>\n<div>\n<p>     <span class=\"uk-label uk-label-success\">Remaining service life<\/span><br \/>\n  <span class=\"uk-label uk-label-success\">Fitness-for-service<\/span><br \/>\n  <span class=\"uk-label uk-label-success\">Post-Market<\/span>\n<\/div>\n<div>\n<h3>Material &#038; welding consulting<\/h3>\n<p>03<\/p>\n<div>\n<p class=\"leist-text\">Consulting on material selection for implants, instruments and medical devices, taking into account biocompatibility, corrosion resistance and manufacturing requirements. Support with material specifications for approval procedures.<\/p>\n<\/div>\n<\/div>\n<div>\n<p>     <span class=\"uk-label uk-label-success\">ISO 10993<\/span><br \/>\n  <span class=\"uk-label uk-label-success\">ISO 5832<\/span><br \/>\n  <span class=\"uk-label uk-label-success\">Implant materials<\/span>\n<\/div>\n<div>\n<p><span class=\"reg-label\">REGULATORY FRAMEWORK<\/span><\/p>\n<p><strong>Standards expertise<\/strong><\/div>\n<div>\n<p>    <span class=\"uk-label\">EU MDR 2017\/745<\/span><br \/>\n  <span class=\"uk-label\">ISO 13485<\/span><br \/>\n  <span class=\"uk-label\">ISO 10993 (biocompatibility)<\/span><br \/>\n  <span class=\"uk-label\">ASTM F2129<\/span><br \/>\n  <span class=\"uk-label\">ISO 5832 (implant materials)<\/span><br \/>\n  <span class=\"uk-label\">VDI 3822<\/span><br \/>\n  <span class=\"uk-label\">DIN EN ISO 6892-1<\/span><\/p>\n<\/div>\n<div>\n<p class=\"section-label\">REGULATION &#038; STANDARDS<\/p>\n<h2>Medical technology requires more than technical expertise &#8211; it requires regulatory understanding.<\/h2>\n<\/div>\n<ul>\n<li>\n<div>Medical Device Regulation<\/div>\n<p>EU MDR 2017\/745<\/p>\n<div>\n<p>Our analyses and material assessments provide standard-compliant evidence for post-market surveillance, vigilance reports and technical documentation in accordance with MDR requirements.<\/p>\n<\/div>\n<\/li>\n<li>\n<div>Quality management system for medical devices<\/div>\n<p>ISO 13485<\/p>\n<div>All testing and analysis results are documented with full traceability &#8211; as seamless evidence for ISO 13485-compliant QM systems and audit procedures.<\/div>\n<\/li>\n<li>\n<div>Corrosion &#038; implant materials<\/div>\n<p>ASTM F2129 &#038; ISO 5832<\/p>\n<div>Electrochemical corrosion testing and material characterization in accordance with ASTM F2129 for implants made of titanium, CoCrMo, stainless steel and other biomaterials.<\/div>\n<\/li>\n<li>\n<div>ISO 14971 &#8211; Risk management<\/div>\n<p>RISK CONTROL<\/p>\n<div>Material-related risks are systematically assessed and documented &#8211; as a basis for risk management systems in accordance with ISO 14971 and for communication with authorities.<\/div>\n<\/li>\n<\/ul>\n<div>\n<p class=\"section-label\">PROJECT REFERENCES (ANONYMIZED)<\/p>\n<h2>From practice &#8211; what we have achieved for manufacturers and operators<\/h2>\n<\/div>\n<ul>\n<li>\n<div>Corrosion analysis of explanted hip implant (CoCrMo)<\/div>\n<p>IMPLANT MANUFACTURER<\/p>\n<div>\n<p class=\"leist-text\">Electrochemical analysis and SEM\/EDX examination after premature implant failure. Crevice corrosion identified as the primary mechanism.<\/p>\n<hr \/>\n<p class=\"leist-text\">\u2192 Standard-compliant expert report prepared for vigilance procedure<\/p>\n<\/div>\n<\/li>\n<li>\n<div>Material qualification for approval procedure (MDR)<\/div>\n<p>MEDICAL DEVICE MANUFACTURER<\/p>\n<div>\n<p class=\"ref-text\"><span>Complete material characterization and biocompatibility evidence in accordance with ISO 10993 for an active implant in the MDR approval procedure.<\/span><\/p>\n<hr \/>\n<p>\u2192 Technical documentation successfully submitted to notified body<\/p>\n<\/div>\n<\/li>\n<li>\n<div>Failure analysis of a fractured surgical instrument<\/div>\n<p>HOSPITAL \/ OPERATOR<\/p>\n<div>\n<p class=\"ref-text\">Fractographic analysis after intraoperative fracture of an instrument. Fatigue failure due to a material defect from manufacturing demonstrated.<\/p>\n<hr \/>\n<p class=\"ref-result\">\u2192 Liability clarification against manufacturer successfully concluded<\/p>\n<\/div>\n<\/li>\n<\/ul>\n<div>\n<p class=\"section-label\">COLLABORATION<\/p>\n<h2>How a collaboration works<\/h2>\n<\/div>\n<hr>\n[receiver]\n<h1>Request<\/h1>\n<div>\n<p>A brief description of your concern &#8211; component, incident or question. By form, email or phone.<\/p>\n<\/div>\n[comments]\n<h1>Initial consultation<\/h1>\n<div>\n<p class=\"prozess-text\">Within 24 hours we get back to you with an initial assessment and agreement on the scope of the investigation.<\/p>\n<\/div>\n[search]\n<h1><span>Analysis<\/span><\/h1>\n<div>\n<p class=\"prozess-text\">Testing in the laboratory or on site. Complete process chain with seamless documentation of all investigation steps.<\/p>\n<\/div>\n[file-edit]\n<h1>\n<p class=\"prozess-title\">Report &amp; consulting<\/p>\n<\/h1>\n<div>\n<p class=\"prozess-text\">Standard-based final report with recommendations for action &#8211; suitable for authorities, insurers and internal QM processes.<\/p>\n<\/div>\n<div>\n<h3>Acute failure case or ongoing revision?<\/h3>\n<div>We are reachable within 24 hours &#8211; worldwide, including in urgent cases.<\/div>\n<p><a href=\"#\">Enquire directly \u2192<\/a><\/p>\n<\/div>\n<div>\n<p class=\"section-label\">WHY TECHNICAL CENTER<\/p>\n<h2>What manufacturers and operators value about our work<\/h2>\n<div class=\"trust-grid\">\n<div class=\"trust-item\">\n<div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<ul>\n<li>\n<div>Regulatory understanding<\/div>\n<div>\n<p><span>We know the requirements of MDR, ISO 13485 and notified bodies &#8211; and deliver documentation that holds up in approval procedures.<\/span><\/p>\n<\/div>\n<\/li>\n<li>\n<div>Seamless traceability<\/div>\n<div>\n<p class=\"trust-desc\"><span>All testing and analysis steps are fully documented &#8211; as a basis for internal QM systems and external audits.<\/span><\/p>\n<\/div>\n<\/li>\n<li>\n<div>Court-proof expert reports<\/div>\n<div>\n<p class=\"trust-desc\"><span>Our reports are structured according to VDI 3822 and designed for use in vigilance procedures, liability disputes and official proceedings.<\/span><\/p>\n<\/div>\n<\/li>\n<li>\n<div>Independent &#038; manufacturer-neutral<\/div>\n<div>\n<p class=\"trust-desc\"><span>No ties to material suppliers or device manufacturers &#8211; we assess objectively and exclusively in the interest of the client.<\/span><\/p>\n<\/div>\n<\/li>\n<\/ul>\n<div>\n<p class=\"section-label\">TYPICAL OCCASIONS<\/p>\n<h2>When manufacturers, operators and lawyers contact us<\/h2>\n<div class=\"use-list\">\n<div class=\"use-item\"><\/div>\n<\/div>\n<\/div>\n<ul>\n<li>\n<div>After a component failure that requires a vigilance report or a notification to the authorities<\/div>\n<\/li>\n<li>\n<div>During an ongoing MDR approval procedure with open material evidence or documentation gaps<\/div>\n<\/li>\n<li>\n<div>In liability disputes between manufacturer, operator and patient<\/div>\n<\/li>\n<li>\n<div>When a decision must be made whether a product can be recalled or remain in use<\/div>\n<\/li>\n<li>\n<div>In the development of new implants or instruments with demanding material requirements<\/div>\n<\/li>\n<li>\n<div>As external expertise for post-market surveillance reports and clinical evaluations<\/div>\n<\/li>\n<\/ul>\n<div>\n<div>No acute case, but a need for clarification regarding material or approval? A non-binding initial assessment is possible.<\/div>\n<p><a href=\"#anfrage-formular\">Request an initial consultation \u2192<\/a><\/p>\n<\/div>\n<div>\n<p class=\"section-label\">FREQUENTLY ASKED QUESTIONS<\/p>\n<\/div>\n<h3>What manufacturers and operators want to know before the first request<\/h3>\n<ul>\n<li>\n<h3>Are your reports suitable for MDR approval procedures and vigilance reports?<\/h3>\n<div>Yes. Our analysis reports are structured according to the standard VDI 3822 and documented with full traceability of all investigation steps. They are designed for use in technical documentation under MDR 2017\/745, vigilance reports and communication with notified bodies.<\/div>\n<\/li>\n<li>\n<h3>Can you also support recall decisions and post-market surveillance?<\/h3>\n<div>Yes. We provide the technical basis for recall decisions: failure analysis, fitness-for-service assessment and remaining service life estimation &#8211; so that manufacturers and operators can decide on the basis of reliable facts.<\/div>\n<\/li>\n<li>\n<h3>How quickly can you respond to an acute incident?<\/h3>\n<div>In acute incidents &#8211; e.g. intraoperative component failure or an ongoing vigilance procedure &#8211; we are reachable within 48 hours. Please briefly describe the urgency and the regulatory context in your request.<\/div>\n<\/li>\n<li>\n<h3>Which materials and product classes do you cover?<\/h3>\n<div>We cover metallic implant materials (titanium, CoCrMo, stainless steel 316L), polymer components, ceramics and coated systems. Product classes include active and passive implants, instruments, housings of medical devices as well as fasteners.<\/div>\n<\/li>\n<li>\n<h3>Can you also act as an external expert in liability disputes?<\/h3>\n<div>Yes. We prepare court-proof expert reports according to VDI 3822 for liability disputes between manufacturers, operators and patients. Our reports are designed for use in court proceedings, arbitration procedures and with insurers.<\/div>\n<\/li>\n<\/ul>\n<p><!--more--><br \/>\n<!-- {\"type\":\"layout\",\"children\":[{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"padding_bottom\":\"xsmall\",\"padding_top\":\"small\",\"style\":\"default\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"breadcrumbs\",\"props\":{\"blend\":false,\"show_current\":true,\"show_home\":true}}]}]}],\"name\":\"1_Breadcrump\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"overlap\":false,\"padding_bottom\":\"none\",\"padding_top\":\"none\",\"preserve_color\":false,\"style\":\"secondary\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"name\":\"Panel Image Right\",\"type\":\"panel\",\"props\":{\"block_align\":\"center\",\"content\":\"\n\n<p><span>For manufacturers, operators and approval managers in medical technology:<br \/>Material consulting, failure analyses and fitness-for-use assessments - standard-compliant, traceable, MDR-compliant.<\/span><\/p>\n\n\\n\n\n<div><span class=\\\"uk-label\\\">MDR-compliant<\/span> <span class=\\\"uk-label\\\">ISO 13485<\/span> <span class=\\\"uk-label\\\">Failure analysis<\/span> <span class=\\\"uk-label\\\">Fitness-For-Service<\/span> <span class=\\\"uk-label\\\">Material consulting<\/span> <span class=\\\"uk-label\\\">Biocompatibility<\/span> <span class=\\\"uk-label\\\">Implants &amp; instruments<\/span><\/div>\n\n\",\"content_column_breakpoint\":\"m\",\"content_margin\":\"small\",\"image\":\"wp-content\/uploads\/2026\/03\/Technical-Center_Medizintechnik.jpg\",\"image_align\":\"right\",\"image_expand\":true,\"image_grid_breakpoint\":\"s\",\"image_grid_width\":\"2-5\",\"image_svg_color\":\"emphasis\",\"image_vertical_align\":true,\"link\":\"#anfrage-formular\",\"link_style\":\"danger\",\"link_text\":\"Submit a request now\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta\":\"- where material failure is not an option\",\"meta_align\":\"below-title\",\"meta_color\":\"danger\",\"meta_element\":\"div\",\"meta_margin\":\"small\",\"meta_style\":\"text-meta\",\"panel_image_no_padding\":true,\"panel_padding\":\"default\",\"panel_style\":\"tile-secondary\",\"title\":\"Materials expertise for medical technology\",\"title_align\":\"top\",\"title_element\":\"h3\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\",\"title_margin\":\"small\"}}]}]}],\"name\":\"2_Header\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"overlap\":true,\"padding_bottom\":\"xsmall\",\"padding_top\":\"xsmall\",\"style\":\"\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"background_color\":\"#FFFFFF\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"section-label\\\">CHALLENGE<\/p>\n\n\\n\n\n<h2 class=\\\"section-title\\\">In medical technology, material failure has immediate consequences - regulatory and clinical.<\/h2>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"grid\",\"props\":{\"content_column_breakpoint\":\"m\",\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"1\",\"grid_medium\":\"\",\"grid_parallax_justify\":true,\"grid_small\":\"2\",\"image_align\":\"top\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"1-2\",\"image_svg_color\":\"emphasis\",\"item_animation\":true,\"lightbox_bg_close\":true,\"link_style\":\"default\",\"link_text\":\"Read more\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"below-title\",\"meta_element\":\"div\",\"meta_margin_auto\":false,\"meta_style\":\"text-meta\",\"panel_padding\":\"small\",\"panel_style\":\"tile-muted\",\"show_content\":true,\"show_hover_image\":false,\"show_hover_video\":false,\"show_image\":false,\"show_link\":false,\"show_meta\":true,\"show_title\":true,\"show_video\":false,\"title_align\":\"top\",\"title_element\":\"h3\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\",\"title_margin_auto\":false},\"children\":[{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<ul>\\n\n\n<li><span>An implant or instrument fails in service - cause and responsibility are unclear.<\/span><\/li>\n\n\\n<\/ul>\n\n\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<ul>\\n\n\n<li><span>Corrosion, fatigue fracture or unexpected embrittlement jeopardize product safety and market approval.<\/span><\/li>\n\n\\n<\/ul>\n\n\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<ul>\\n\n\n<li><span>Is a component still safe to use after an incident - or must it be recalled?<\/span><\/li>\n\n\\n<\/ul>\n\n\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<ul>\\n\n\n<li><span>What caused the failure - and how do we prevent it from recurring?<\/span><\/li>\n\n\\n<\/ul>\n\n\"}}]}]}]}],\"name\":\"3_Herausforderungen\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"padding_bottom\":\"xsmall\",\"padding_top\":\"xsmall\",\"style\":\"default\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"grid\",\"props\":{\"content_align\":false,\"content_column_breakpoint\":\"m\",\"content_margin\":\"small\",\"content_margin_auto\":true,\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"1\",\"grid_masonry\":\"pack\",\"grid_medium\":\"\",\"grid_parallax\":\"0\",\"grid_parallax_justify\":false,\"image_align\":\"left\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"auto\",\"image_svg_color\":\"muted\",\"image_svg_inline\":false,\"item_animation\":true,\"lightbox\":false,\"lightbox_bg_close\":true,\"link_fullwidth\":false,\"link_size\":\"small\",\"link_style\":\"secondary\",\"link_text\":\"Enquire directly \u2192\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"below-title\",\"meta_element\":\"div\",\"meta_style\":\"text-meta\",\"panel_image_no_padding\":false,\"panel_padding\":\"small\",\"panel_style\":\"card-primary\",\"show_content\":true,\"show_hover_image\":true,\"show_hover_video\":true,\"show_image\":true,\"show_link\":true,\"show_meta\":true,\"show_title\":true,\"show_video\":true,\"title_align\":\"top\",\"title_element\":\"h3\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\",\"title_style\":\"h3\"},\"children\":[{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<div class=\\\"cta-strip-left\\\">\\n\n\n<div class=\\\"cta-strip-text\\\"><span>We analyse, document and deliver standard-compliant foundations - reachable within 24 hours.<\/span><\/div>\n\n\\n<\/div>\n\n\",\"icon\":\"clock\",\"link\":\"#anfrage-formular\",\"link_text\":\"Enquire directly \u2192\",\"title\":\"Component failure, recall or ongoing approval procedure?\"}}]}]}]}],\"name\":\"4_24h-Erreichbarkeit\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"padding_bottom\":\"xsmall\",\"padding_top\":\"xsmall\",\"style\":\"\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"background_color\":\"#FFFFFF\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"section-label\\\">SERVICES<\/p>\n\n\\n\n\n<h2>Our services for medical technology<\/h2>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"fragment\",\"props\":{\"margin_bottom\":\"default\",\"margin_top\":\"default\"},\"children\":[{\"type\":\"row\",\"props\":{\"layout\":\"1-3,1-3,1-3\",\"margin_top\":\"small\"},\"children\":[{\"type\":\"column\",\"props\":{\"background_color\":\"#EEF1F4\",\"image_position\":\"center-center\",\"padding\":\"xsmall\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"1-3\"},\"children\":[{\"type\":\"grid\",\"props\":{\"content_column_breakpoint\":\"m\",\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"1\",\"grid_masonry\":\"pack\",\"grid_medium\":\"\",\"image_align\":\"top\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"1-2\",\"image_svg_color\":\"emphasis\",\"item_animation\":true,\"lightbox_bg_close\":true,\"link_style\":\"default\",\"link_text\":\"Read more\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"above-title\",\"meta_color\":\"danger\",\"meta_element\":\"div\",\"meta_style\":\"text-meta\",\"show_content\":true,\"show_hover_image\":true,\"show_hover_video\":true,\"show_image\":true,\"show_link\":true,\"show_meta\":true,\"show_title\":true,\"show_video\":true,\"title_align\":\"top\",\"title_element\":\"h3\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\"},\"children\":[{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p class=\\\"leist-text\\\">Systematic root cause investigation in component failure - implants, instruments, housings, fasteners. Fractography, metallography, EDX analysis. Standard-based documentation according to VDI 3822 for authorities, insurers and manufacturers.<\/p>\n\n\",\"meta\":\"01\",\"title\":\"Forensic failure analysis\"}}]},{\"type\":\"html\",\"props\":{\"content\":\"<span class=\\\"uk-label uk-label-success\\\">VDI 3822<\/span>\\n  <span class=\\\"uk-label uk-label-success\\\">SEM \/ EDX<\/span>\\n  <span class=\\\"uk-label uk-label-success\\\">Fractography<\/span>\\n  <span class=\\\"uk-label uk-label-success\\\">MDR documentation<\/span>\"}}]},{\"type\":\"column\",\"props\":{\"background_color\":\"#EEF1F4\",\"image_position\":\"center-center\",\"padding\":\"xsmall\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"1-3\"},\"children\":[{\"type\":\"grid\",\"props\":{\"content_column_breakpoint\":\"m\",\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"1\",\"grid_masonry\":\"pack\",\"grid_medium\":\"\",\"image_align\":\"top\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"1-2\",\"image_svg_color\":\"emphasis\",\"item_animation\":true,\"lightbox_bg_close\":true,\"link_style\":\"default\",\"link_text\":\"Read more\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"above-title\",\"meta_color\":\"danger\",\"meta_element\":\"div\",\"meta_style\":\"text-meta\",\"show_content\":true,\"show_hover_image\":true,\"show_hover_video\":true,\"show_image\":true,\"show_link\":true,\"show_meta\":true,\"show_title\":true,\"show_video\":true,\"title_align\":\"top\",\"title_element\":\"h3\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\"},\"children\":[{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p class=\\\"leist-text\\\">Objective assessment of the fitness-for-service of components and systems - including after incidents or changed operating conditions. Estimation of safe remaining service lives as a basis for continued-operation or recall decisions.<\/p>\n\n\",\"meta\":\"02\",\"title\":\"Fitness-For-Service analyses\"}}]},{\"type\":\"html\",\"props\":{\"content\":\" <span class=\\\"uk-label uk-label-success\\\">Remaining service life<\/span>\\n  <span class=\\\"uk-label uk-label-success\\\">Fitness-for-service<\/span>\\n  <span class=\\\"uk-label uk-label-success\\\">Post-Market<\/span>\"}}]},{\"type\":\"column\",\"props\":{\"background_color\":\"#EEF1F4\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"1-3\"},\"children\":[{\"type\":\"grid\",\"props\":{\"content_column_breakpoint\":\"m\",\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"1\",\"grid_masonry\":\"pack\",\"grid_medium\":\"\",\"image_align\":\"top\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"1-2\",\"image_svg_color\":\"emphasis\",\"item_animation\":true,\"lightbox_bg_close\":true,\"link_style\":\"default\",\"link_text\":\"Read more\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"above-title\",\"meta_color\":\"danger\",\"meta_element\":\"div\",\"meta_style\":\"text-meta\",\"show_content\":true,\"show_hover_image\":true,\"show_hover_video\":true,\"show_image\":true,\"show_link\":true,\"show_meta\":true,\"show_title\":true,\"show_video\":true,\"title_align\":\"top\",\"title_element\":\"h3\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\"},\"children\":[{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p class=\\\"leist-text\\\">Consulting on material selection for implants, instruments and medical devices, taking into account biocompatibility, corrosion resistance and manufacturing requirements. Support with material specifications for approval procedures.<\/p>\n\n\",\"meta\":\"03\",\"title\":\"Material & welding consulting\"}}]},{\"type\":\"html\",\"props\":{\"content\":\" <span class=\\\"uk-label uk-label-success\\\">ISO 10993<\/span>\\n  <span class=\\\"uk-label uk-label-success\\\">ISO 5832<\/span>\\n  <span class=\\\"uk-label uk-label-success\\\">Implant materials<\/span>\"}}]}]}]}]}]}],\"name\":\"5_Leistungen\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"overlap\":false,\"padding_bottom\":\"xsmall\",\"padding_top\":\"small\",\"style\":\"default\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"background_color\":\"#14243B\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"1-3\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p><span class=\\\"reg-label\\\">REGULATORY FRAMEWORK<\/span><\/p>\n\n\\n<strong>Standards expertise<\/strong>\",\"dropcap\":false,\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_color\":\"muted\"}}]},{\"type\":\"column\",\"props\":{\"background_color\":\"#14243B\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"2-3\"},\"children\":[{\"type\":\"html\",\"props\":{\"content\":\"<span class=\\\"uk-label\\\">EU MDR 2017\/745<\/span>\\n  <span class=\\\"uk-label\\\">ISO 13485<\/span>\\n  <span class=\\\"uk-label\\\">ISO 10993 (biocompatibility)<\/span>\\n  <span class=\\\"uk-label\\\">ASTM F2129<\/span>\\n  <span class=\\\"uk-label\\\">ISO 5832 (implant materials)<\/span>\\n  <span class=\\\"uk-label\\\">VDI 3822<\/span>\\n  <span class=\\\"uk-label\\\">DIN EN ISO 6892-1<\/span>\\n\\n\"}}]}],\"props\":{\"column_gap\":\"collapse\",\"divider\":true,\"layout\":\"1-3,2-3\",\"margin_bottom\":\"small\",\"parallax\":false,\"row_gap\":\"collapse\"}}],\"name\":\"6_Normenkompetenz\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"padding_bottom\":\"xsmall\",\"padding_top\":\"xsmall\",\"style\":\"\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"background_color\":\"#FFFFFF\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"section-label\\\">REGULATION & STANDARDS<\/p>\n\n\\n\n\n<h2>Medical technology requires more than technical expertise - it requires regulatory understanding.<\/h2>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"grid\",\"props\":{\"animation\":\"none\",\"content_column_breakpoint\":\"m\",\"content_style\":\"text-small\",\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"1\",\"grid_large\":\"2\",\"grid_medium\":\"2\",\"grid_parallax\":\"0\",\"grid_parallax_justify\":true,\"grid_small\":\"2\",\"grid_xlarge\":\"2\",\"image_align\":\"top\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"1-2\",\"image_svg_color\":\"emphasis\",\"item_animation\":true,\"lightbox_bg_close\":true,\"link_margin\":\"xsmall\",\"link_style\":\"link-text\",\"link_text\":\"Read more\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"above-title\",\"meta_color\":\"danger\",\"meta_element\":\"div\",\"meta_style\":\"text-meta\",\"panel_padding\":\"small\",\"show_content\":true,\"show_hover_image\":false,\"show_hover_video\":false,\"show_image\":false,\"show_link\":true,\"show_meta\":true,\"show_title\":true,\"show_video\":false,\"title_align\":\"top\",\"title_element\":\"div\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\",\"title_style\":\"h5\"},\"children\":[{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p>Our analyses and material assessments provide standard-compliant evidence for post-market surveillance, vigilance reports and technical documentation in accordance with MDR requirements.<\/p>\n\n\",\"icon\":\"arrow-right\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 Continued operation approved for 3 further revision cycles\",\"meta\":\"EU MDR 2017\/745\",\"panel_style\":\"card-secondary\",\"title\":\"Medical Device Regulation\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"All testing and analysis results are documented with full traceability - as seamless evidence for ISO 13485-compliant QM systems and audit procedures.\",\"icon\":\"arrow-right\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 Continued operation approved for 3 further revision cycles\",\"meta\":\"ISO 13485\",\"panel_style\":\"card-secondary\",\"title\":\"Quality management system for medical devices\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"Electrochemical corrosion testing and material characterization in accordance with ASTM F2129 for implants made of titanium, CoCrMo, stainless steel and other biomaterials.\",\"icon\":\"arrow-right\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 Continued operation approved for 3 further revision cycles\",\"meta\":\"ASTM F2129 & ISO 5832\",\"panel_style\":\"card-secondary\",\"title\":\"Corrosion & implant materials\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"Material-related risks are systematically assessed and documented - as a basis for risk management systems in accordance with ISO 14971 and for communication with authorities.\",\"icon\":\"arrow-right\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 Continued operation approved for 3 further revision cycles\",\"meta\":\"RISK CONTROL\",\"panel_style\":\"card-secondary\",\"title\":\"ISO 14971 - Risk management\"}}]}]}]}],\"name\":\"7_Branchenwissen\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"padding_bottom\":\"xsmall\",\"padding_top\":\"xsmall\",\"style\":\"\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"background_color\":\"#FFFFFF\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"section-label\\\">PROJECT REFERENCES (ANONYMIZED)<\/p>\n\n\\n\n\n<h2>From practice - what we have achieved for manufacturers and operators<\/h2>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"grid\",\"props\":{\"animation\":\"none\",\"content_column_breakpoint\":\"m\",\"content_style\":\"text-small\",\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"1\",\"grid_large\":\"3\",\"grid_medium\":\"3\",\"grid_parallax_justify\":true,\"grid_small\":\"1\",\"grid_xlarge\":\"3\",\"image_align\":\"top\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"1-2\",\"image_svg_color\":\"emphasis\",\"item_animation\":true,\"lightbox_bg_close\":true,\"link_margin\":\"xsmall\",\"link_style\":\"link-text\",\"link_text\":\"Read more\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"above-title\",\"meta_color\":\"danger\",\"meta_element\":\"div\",\"meta_style\":\"text-meta\",\"panel_padding\":\"small\",\"show_content\":true,\"show_hover_image\":false,\"show_hover_video\":false,\"show_image\":false,\"show_link\":true,\"show_meta\":true,\"show_title\":true,\"show_video\":false,\"title_align\":\"top\",\"title_element\":\"div\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\",\"title_style\":\"h5\"},\"children\":[{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p class=\\\"leist-text\\\">Electrochemical analysis and SEM\/EDX examination after premature implant failure. Crevice corrosion identified as the primary mechanism.<\/p>\n\n\\n\n\n<hr \/>\n\n\\n\n\n<p class=\\\"leist-text\\\">\u2192 Standard-compliant expert report prepared for vigilance procedure<\/p>\n\n\",\"icon\":\"arrow-right\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 Continued operation approved for 3 further revision cycles\",\"meta\":\"IMPLANT MANUFACTURER\",\"panel_style\":\"card-overlay\",\"title\":\"Corrosion analysis of explanted hip implant (CoCrMo)\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p class=\\\"ref-text\\\"><span>Complete material characterization and biocompatibility evidence in accordance with ISO 10993 for an active implant in the MDR approval procedure.<\/span><\/p>\n\n\\n\n\n<hr \/>\n\n\\n\n\n<p>\u2192 Technical documentation successfully submitted to notified body<\/p>\n\n\",\"icon\":\"arrow-right\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 KTA-compliant acceptance successfully completed\",\"meta\":\"MEDICAL DEVICE MANUFACTURER\",\"panel_style\":\"card-overlay\",\"title\":\"Material qualification for approval procedure (MDR)\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p class=\\\"ref-text\\\">Fractographic analysis after intraoperative fracture of an instrument. Fatigue failure due to a material defect from manufacturing demonstrated.<\/p>\n\n\\n\n\n<hr \/>\n\n\\n\n\n<p class=\\\"ref-result\\\">\u2192 Liability clarification against manufacturer successfully concluded<\/p>\n\n\",\"icon\":\"arrow-right\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 Protection concept developed, warranty claim enforced\",\"meta\":\"HOSPITAL \/ OPERATOR\",\"panel_style\":\"card-overlay\",\"title\":\"Failure analysis of a fractured surgical instrument\"}}]}]}]}],\"name\":\"8_Referenzen\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"padding_bottom\":\"xsmall\",\"padding_top\":\"xsmall\",\"style\":\"\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"background_color\":\"#FFFFFF\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"section-label\\\">COLLABORATION<\/p>\n\n\\n\n\n<h2>How a collaboration works<\/h2>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"divider\",\"props\":{\"divider_element\":\"hr\"}},{\"type\":\"fragment\",\"props\":{\"margin_bottom\":\"default\",\"margin_top\":\"default\"},\"children\":[{\"type\":\"row\",\"props\":{\"layout\":\"1-4,1-4,1-4,1-4|1-2,1-2,1-2,1-2\"},\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"1-4\",\"width_small\":\"1-2\"},\"children\":[{\"type\":\"icon\",\"props\":{\"icon\":\"receiver\",\"icon_color\":\"danger\",\"icon_width\":\"40\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_align\":\"center\"}},{\"type\":\"headline\",\"props\":{\"content\":\"Request\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"text_align\":\"center\",\"title_element\":\"h1\",\"title_style\":\"h3\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>A brief description of your concern - component, incident or question. By form, email or phone.<\/p>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_align\":\"center\"}}]},{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"1-4\",\"width_small\":\"1-2\"},\"children\":[{\"type\":\"icon\",\"props\":{\"icon\":\"comments\",\"icon_color\":\"danger\",\"icon_width\":\"40\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_align\":\"center\"}},{\"type\":\"headline\",\"props\":{\"content\":\"Initial consultation\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"text_align\":\"center\",\"title_element\":\"h1\",\"title_style\":\"h3\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"prozess-text\\\">Within 24 hours we get back to you with an initial assessment and agreement on the scope of the investigation.<\/p>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_align\":\"center\"}}]},{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"1-4\",\"width_small\":\"1-2\"},\"children\":[{\"type\":\"icon\",\"props\":{\"icon\":\"search\",\"icon_color\":\"danger\",\"icon_width\":\"40\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_align\":\"center\"}},{\"type\":\"headline\",\"props\":{\"content\":\"<span>Analysis<\/span>\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"text_align\":\"center\",\"title_element\":\"h1\",\"title_style\":\"h3\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"prozess-text\\\">Testing in the laboratory or on site. Complete process chain with seamless documentation of all investigation steps.<\/p>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_align\":\"center\"}}]},{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"1-4\",\"width_small\":\"1-2\"},\"children\":[{\"type\":\"icon\",\"props\":{\"icon\":\"file-edit\",\"icon_color\":\"danger\",\"icon_width\":\"40\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_align\":\"center\"}},{\"type\":\"headline\",\"props\":{\"content\":\"\n\n<p class=\\\"prozess-title\\\">Report &amp; consulting<\/p>\n\n\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"text_align\":\"center\",\"title_element\":\"h1\",\"title_style\":\"h3\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"prozess-text\\\">Standard-based final report with recommendations for action - suitable for authorities, insurers and internal QM processes.<\/p>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_align\":\"center\"}}]}]}]}]}]},{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"grid\",\"props\":{\"content_align\":false,\"content_column_breakpoint\":\"m\",\"content_margin\":\"small\",\"content_margin_auto\":true,\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"1\",\"grid_masonry\":\"pack\",\"grid_medium\":\"\",\"grid_parallax\":\"0\",\"grid_parallax_justify\":false,\"image_align\":\"left\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"auto\",\"image_svg_color\":\"muted\",\"image_svg_inline\":false,\"item_animation\":true,\"lightbox\":false,\"lightbox_bg_close\":true,\"link_fullwidth\":false,\"link_size\":\"small\",\"link_style\":\"secondary\",\"link_text\":\"Enquire directly \u2192\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"below-title\",\"meta_element\":\"div\",\"meta_style\":\"text-meta\",\"panel_image_no_padding\":false,\"panel_padding\":\"small\",\"panel_style\":\"card-primary\",\"show_content\":true,\"show_hover_image\":true,\"show_hover_video\":true,\"show_image\":true,\"show_link\":true,\"show_meta\":true,\"show_title\":true,\"show_video\":true,\"title_align\":\"top\",\"title_element\":\"h3\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\",\"title_style\":\"h3\"},\"children\":[{\"type\":\"grid_item\",\"props\":{\"content\":\"We are reachable within 24 hours - worldwide, including in urgent cases.\",\"icon\":\"future\",\"link\":\"#\",\"link_text\":\"Enquire directly \u2192\",\"title\":\"Acute failure case or ongoing revision?\"}}]}]}]}],\"name\":\"9_Ablauf-Zusammenarbeit\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"padding_bottom\":\"xsmall\",\"padding_top\":\"xsmall\",\"style\":\"\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"background_color\":\"#FFFFFF\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"section-label\\\">WHY TECHNICAL CENTER<\/p>\n\n\\n\n\n<h2>What manufacturers and operators value about our work<\/h2>\n\n\\n\n\n<div class=\\\"trust-grid\\\">\\n\n\n<div class=\\\"trust-item\\\">\\n\n\n<div><\/div>\n\n\\n<\/div>\n\n\\n<\/div>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"grid\",\"props\":{\"animation\":\"none\",\"content_column_breakpoint\":\"m\",\"content_style\":\"text-small\",\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"1\",\"grid_large\":\"2\",\"grid_medium\":\"2\",\"grid_parallax_justify\":true,\"grid_small\":\"2\",\"grid_xlarge\":\"2\",\"image_align\":\"left\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"auto\",\"image_svg_color\":\"emphasis\",\"item_animation\":true,\"lightbox_bg_close\":true,\"link_margin\":\"xsmall\",\"link_style\":\"link-text\",\"link_text\":\"Read more\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"above-title\",\"meta_color\":\"danger\",\"meta_element\":\"div\",\"meta_style\":\"text-meta\",\"panel_padding\":\"small\",\"panel_style\":\"tile-muted\",\"show_content\":true,\"show_hover_image\":false,\"show_hover_video\":false,\"show_image\":true,\"show_link\":true,\"show_meta\":true,\"show_title\":true,\"show_video\":false,\"title_align\":\"top\",\"title_element\":\"div\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\",\"title_style\":\"h6\"},\"children\":[{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p><span>We know the requirements of MDR, ISO 13485 and notified bodies - and deliver documentation that holds up in approval procedures.<\/span><\/p>\n\n\",\"icon\":\"file-text\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 Continued operation approved for 3 further revision cycles\",\"meta\":\"\",\"title\":\"Regulatory understanding\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p class=\\\"trust-desc\\\"><span>All testing and analysis steps are fully documented - as a basis for internal QM systems and external audits.<\/span><\/p>\n\n\",\"icon\":\"check\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 Continued operation approved for 3 further revision cycles\",\"meta\":\"\",\"title\":\"Seamless traceability\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p class=\\\"trust-desc\\\"><span>Our reports are structured according to VDI 3822 and designed for use in vigilance procedures, liability disputes and official proceedings.<\/span><\/p>\n\n\",\"icon\":\"file-edit\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 Continued operation approved for 3 further revision cycles\",\"meta\":\"\",\"title\":\"Court-proof expert reports\"}},{\"type\":\"grid_item\",\"props\":{\"content\":\"\n\n<p class=\\\"trust-desc\\\"><span>No ties to material suppliers or device manufacturers - we assess objectively and exclusively in the interest of the client.<\/span><\/p>\n\n\",\"icon\":\"heart\",\"link_style\":\"link-text\",\"link_text\":\"\u2192 Continued operation approved for 3 further revision cycles\",\"meta\":\"\",\"title\":\"Independent & manufacturer-neutral\"}}]}]}]}],\"name\":\"10_WARUM TECHNICAL CENTER\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"padding_bottom\":\"xsmall\",\"padding_top\":\"xsmall\",\"style\":\"\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"background_color\":\"#FFFFFF\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"section-label\\\">TYPICAL OCCASIONS<\/p>\n\n\\n\n\n<h2>When manufacturers, operators and lawyers contact us<\/h2>\n\n\\n\n\n<div class=\\\"use-list\\\">\\n\n\n<div class=\\\"use-item\\\"><\/div>\n\n\\n<\/div>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"list\",\"props\":{\"animation\":\"none\",\"column_breakpoint\":\"m\",\"image_align\":\"left\",\"image_svg_color\":\"emphasis\",\"image_vertical_align\":true,\"list_element\":\"ul\",\"list_horizontal_separator\":\", \",\"list_style\":\"striped\",\"list_type\":\"vertical\",\"show_image\":true,\"show_link\":true},\"children\":[{\"type\":\"list_item\",\"props\":{\"content\":\"After a component failure that requires a vigilance report or a notification to the authorities\",\"icon\":\"check\"}},{\"type\":\"list_item\",\"props\":{\"content\":\"During an ongoing MDR approval procedure with open material evidence or documentation gaps\",\"icon\":\"check\"}},{\"type\":\"list_item\",\"props\":{\"content\":\"In liability disputes between manufacturer, operator and patient\",\"icon\":\"check\"}},{\"type\":\"list_item\",\"props\":{\"content\":\"When a decision must be made whether a product can be recalled or remain in use\",\"icon\":\"check\"}},{\"type\":\"list_item\",\"props\":{\"content\":\"In the development of new implants or instruments with demanding material requirements\",\"icon\":\"check\"}},{\"type\":\"list_item\",\"props\":{\"content\":\"As external expertise for post-market surveillance reports and clinical evaluations\",\"icon\":\"check\"}}]}]}]}],\"name\":\"11_TYPISCHE ANL\u00c4SSE\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"padding_bottom\":\"xsmall\",\"padding_top\":\"xsmall\",\"style\":\"default\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"grid\",\"props\":{\"content_align\":false,\"content_column_breakpoint\":\"m\",\"content_margin\":\"small\",\"content_margin_auto\":true,\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"1\",\"grid_masonry\":\"pack\",\"grid_medium\":\"\",\"grid_parallax\":\"0\",\"grid_parallax_justify\":false,\"image_align\":\"left\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"auto\",\"image_svg_color\":\"muted\",\"image_svg_inline\":false,\"item_animation\":true,\"lightbox\":false,\"lightbox_bg_close\":true,\"link_fullwidth\":false,\"link_size\":\"small\",\"link_style\":\"secondary\",\"link_text\":\"Enquire directly \u2192\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"below-title\",\"meta_element\":\"div\",\"meta_style\":\"text-meta\",\"panel_image_no_padding\":false,\"panel_padding\":\"small\",\"panel_style\":\"card-secondary\",\"show_content\":true,\"show_hover_image\":true,\"show_hover_video\":true,\"show_image\":true,\"show_link\":true,\"show_meta\":true,\"show_title\":true,\"show_video\":true,\"title_align\":\"top\",\"title_color\":\"secondary\",\"title_element\":\"div\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\",\"title_style\":\"text-large\"},\"children\":[{\"type\":\"grid_item\",\"props\":{\"content\":\"No acute case, but a need for clarification regarding material or approval? A non-binding initial assessment is possible.\",\"icon\":\"\",\"link\":\"#anfrage-formular\",\"link_text\":\"Request an initial consultation \u2192\",\"title\":\"\"}}]}]}]}],\"name\":\"12_Erstgespr\u00e4ch\"},{\"type\":\"section\",\"props\":{\"image_position\":\"center-center\",\"padding_bottom\":\"xsmall\",\"padding_top\":\"xsmall\",\"style\":\"\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"default\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"background_color\":\"#FFFFFF\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p class=\\\"section-label\\\">FREQUENTLY ASKED QUESTIONS<\/p>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_color\":\"warning\",\"text_style\":\"meta\"}},{\"type\":\"headline\",\"props\":{\"content\":\"What manufacturers and operators want to know before the first request\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"margin_bottom\":\"large\",\"title_color\":\"secondary\",\"title_decoration\":\"bullet\",\"title_element\":\"h3\",\"title_font_family\":\"secondary\",\"title_style\":\"h1\"}},{\"name\":\"Accordion Multiple Items Start Closed\",\"type\":\"accordion\",\"children\":[{\"type\":\"accordion_item\",\"props\":{\"content\":\"Yes. Our analysis reports are structured according to the standard VDI 3822 and documented with full traceability of all investigation steps. They are designed for use in technical documentation under MDR 2017\/745, vigilance reports and communication with notified bodies.\",\"title\":\"Are your reports suitable for MDR approval procedures and vigilance reports?\"}},{\"type\":\"accordion_item\",\"props\":{\"content\":\"Yes. We provide the technical basis for recall decisions: failure analysis, fitness-for-service assessment and remaining service life estimation - so that manufacturers and operators can decide on the basis of reliable facts.\",\"title\":\"Can you also support recall decisions and post-market surveillance?\"}},{\"type\":\"accordion_item\",\"props\":{\"content\":\"In acute incidents - e.g. intraoperative component failure or an ongoing vigilance procedure - we are reachable within 48 hours. Please briefly describe the urgency and the regulatory context in your request.\",\"title\":\"How quickly can you respond to an acute incident?\"}},{\"type\":\"accordion_item\",\"props\":{\"content\":\"We cover metallic implant materials (titanium, CoCrMo, stainless steel 316L), polymer components, ceramics and coated systems. Product classes include active and passive implants, instruments, housings of medical devices as well as fasteners.\",\"title\":\"Which materials and product classes do you cover?\"}},{\"type\":\"accordion_item\",\"props\":{\"content\":\"Yes. We prepare court-proof expert reports according to VDI 3822 for liability disputes between manufacturers, operators and patients. Our reports are designed for use in court proceedings, arbitration procedures and with insurers.\",\"title\":\"Can you also act as an external expert in liability disputes?\"}}],\"props\":{\"block_align\":\"center\",\"collapsible\":true,\"content_column_breakpoint\":\"m\",\"image_align\":\"top\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"1-2\",\"image_svg_color\":\"emphasis\",\"link_style\":\"default\",\"link_text\":\"Read more\",\"multiple\":true,\"show_image\":true,\"show_link\":true}}]}]}],\"name\":\"13_FAQ\"}],\"version\":\"5.0.29\"} --><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Materials expertise for medical technology &#8211; where material failure is not an option For manufacturers, operators and approval managers in medical technology:Material consulting, failure analyses and fitness-for-use assessments &#8211; standard-compliant, traceable, MDR-compliant. MDR-compliant ISO 13485 Failure analysis Fitness-For-Service Material consulting Biocompatibility Implants &amp; instruments Submit a request now CHALLENGE In medical technology, material failure has [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-3109","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.technical-center.de\/en\/wp-json\/wp\/v2\/pages\/3109","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.technical-center.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.technical-center.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.technical-center.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.technical-center.de\/en\/wp-json\/wp\/v2\/comments?post=3109"}],"version-history":[{"count":0,"href":"https:\/\/www.technical-center.de\/en\/wp-json\/wp\/v2\/pages\/3109\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.technical-center.de\/en\/wp-json\/wp\/v2\/media?parent=3109"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.technical-center.de\/en\/wp-json\/wp\/v2\/categories?post=3109"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.technical-center.de\/en\/wp-json\/wp\/v2\/tags?post=3109"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}