{"id":9691,"date":"2025-11-04T07:00:20","date_gmt":"2025-11-04T06:00:20","guid":{"rendered":"https:\/\/medtech-ingenieur.de\/?p=9691"},"modified":"2025-11-10T10:23:13","modified_gmt":"2025-11-10T09:23:13","slug":"medizintechnik-fertigungsunterlagen-pruefen","status":"publish","type":"post","link":"https:\/\/medtech-ingenieur.de\/en\/medizintechnik-fertigungsunterlagen-pruefen\/","title":{"rendered":"Manufacturing documents in medical technology"},"content":{"rendered":"<h2>How to check your production documentation for audit readiness<\/h2>\n<p data-end=\"600\" data-start=\"356\">Once production starts, it&#039;s too late for uncertainties in the documentation. A missing test report, unclear work instructions, or an incomplete FMEA \u2013 and the audit or series release is already at risk.<\/p>\n<p data-end=\"924\" data-start=\"602\">To prevent exactly that from happening, we check your production documents before they go into manufacturing. With our <strong data-end=\"748\" data-start=\"721\">Production-Ready Report<\/strong> We ensure that your documentation is complete, traceable and audit-ready \u2013 <strong data-end=\"868\" data-start=\"847\">according to EN ISO 13485<\/strong> and with the perspective of experienced medical technology engineers.<\/p>\n<h3>Why is an independent review of the manufacturing documentation crucial?<\/h3>\n<p data-end=\"1283\" data-start=\"1012\">Many projects show that gaps often arise between the completion of development and series production. Interfaces between development, quality assurance, and production quickly lead to missing or inconsistent documentation \u2013 a risk for any audit.<\/p>\n<p data-end=\"1343\" data-start=\"1285\"><strong data-end=\"1343\" data-start=\"1285\">Typical pitfalls in manufacturing documentation:<\/strong><\/p>\n<ul>\n<li data-end=\"1395\" data-start=\"1346\">Missing or inconsistent work instructions<\/li>\n<li data-end=\"1457\" data-start=\"1398\">Incomprehensible version levels of specifications<\/li>\n<li data-end=\"1520\" data-start=\"1460\">Unclear test criteria or missing test equipment definitions<\/li>\n<li data-end=\"1559\" data-start=\"1523\">FMEAs without current process risks<\/li>\n<li data-end=\"1611\" data-start=\"1562\">Manufacturing processes that are not fully validated<\/li>\n<\/ul>\n<p>These weaknesses often only come to light during an audit \u2013 when it becomes expensive and time-critical. That&#039;s why we start earlier: We review your documents before production begins.<\/p>\n<h2 data-end=\"1881\" data-start=\"1804\"><strong data-end=\"1881\" data-start=\"1807\">The MEDtech Production-Ready Report: Your audit check for manufacturing<\/strong><\/h2>\n<p data-end=\"2237\" data-start=\"1883\">In the <strong data-end=\"1913\" data-start=\"1886\">Production-Ready Report<\/strong> Our experts analyze the documents necessary for smooth and compliant manufacturing. From specifications and work instructions to FMEAs and validations, we check whether all content is complete, up-to-date, and traceable \u2013 with a focus on the requirements of the <strong data-end=\"2236\" data-start=\"2220\">EN ISO 13485<\/strong>.<\/p>\n<h1>This is how the process works.<\/h1>\n<h1 style=\"\">The Production Ready Report<\/h1>\n<h2 data-end=\"3748\" data-start=\"3713\"><strong data-end=\"3748\" data-start=\"3716\">Your added value at a glance<\/strong><\/h2>\n<ul>\n<li><span style=\"\">Security for internal and external audits<\/span><\/li>\n<li><span style=\"\">Clarity regarding the status of your manufacturing documents<\/span><\/li>\n<li><span style=\"\">Clear assessment and concrete to-dos<\/span><\/li>\n<li><span style=\"\">Standard-compliant analysis according to EN ISO 13485<\/span><\/li>\n<li><span style=\"\">Technical support from experienced MedTech engineers<\/span><\/li>\n<\/ul>\n<h2 data-end=\"4069\" data-start=\"4012\"><strong data-end=\"4069\" data-start=\"4015\">Practical example: Series release without surprises<\/strong><\/h2>\n<p data-end=\"4314\" data-start=\"4071\">A customer was on the verge of receiving serial production approval for their new medical device. An internal audit revealed that several validation certificates were missing and some work instructions did not comply with the current specifications.<\/p>\n<p data-end=\"4559\" data-start=\"4316\">Within a few days, we reviewed all the documents, identified gaps, and provided recommendations for further documentation. The result: Series production was approved without any issues \u2013 and the customer started production on time.<\/p>\n<h2 data-end=\"4602\" data-start=\"4566\"><strong data-end=\"4602\" data-start=\"4569\">Get Production Ready Now<\/strong><\/h2>\n<p data-end=\"4773\" data-start=\"4604\">Do you want to know if your production documentation is truly audit-ready? Then start with a free initial consultation with our manufacturing experts or take a look at our complete service portfolio for <span style=\"color: var(--tcb-skin-color-2) !important;\"><a href=\"https:\/\/medtech-ingenieur.de\/en\/auftragsfertigung-medizintechnik\/\" target=\"_blank\" style=\"outline: none;\"><span style=\"--tcb-applied-color: var$(--tcb-skin-color-2) !important;\">Production &amp; Manufacturing<\/span><\/a><\/span> to.<\/p>\n<p data-end=\"4890\" data-start=\"4775\">Together we will bring your manufacturing <strong data-end=\"4888\" data-start=\"4815\">To the point \u2013 audit-proof, efficient and ready for production.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>So pr\u00fcfen Sie Ihre Produktionsdokumentation auf Audit-Tauglichkeit Wenn die Produktion startet, ist es zu sp\u00e4t f\u00fcr Unsicherheiten in der Dokumentation.Ein fehlendes Pr\u00fcfprotokoll, eine unklare Arbeitsanweisung oder eine unvollst\u00e4ndige FMEA \u2013 und schon steht das Audit oder die Serienfreigabe auf der Kippe. Damit genau das nicht passiert, pr\u00fcfen wir Ihre Produktionsunterlagen, bevor Sie in die Fertigung [&hellip;]<\/p>\n","protected":false},"author":49,"featured_media":10870,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","tve_updated_post":"<div class=\"thrv_wrapper thrv_text_element\"><h2 class=\"\">So pr\u00fcfen Sie Ihre Produktionsdokumentation auf Audit-Tauglichkeit<\/h2><p data-end=\"600\" data-start=\"356\">Wenn die Produktion startet, ist es zu sp\u00e4t f\u00fcr Unsicherheiten in der Dokumentation.<br data-start=\"440\" data-end=\"443\">Ein fehlendes Pr\u00fcfprotokoll, eine unklare Arbeitsanweisung oder eine unvollst\u00e4ndige FMEA \u2013 und schon steht das Audit oder die Serienfreigabe auf der Kippe.<\/p><p data-end=\"924\" data-start=\"602\">Damit genau das nicht passiert, pr\u00fcfen wir Ihre Produktionsunterlagen, bevor Sie in die Fertigung gehen.<br data-start=\"706\" data-end=\"709\">Mit unserem <strong data-end=\"748\" data-start=\"721\">Production-Ready-Report<\/strong> stellen wir sicher, dass Ihre Dokumentation vollst\u00e4ndig, nachvollziehbar und audit-tauglich ist \u2013 <strong data-end=\"868\" data-start=\"847\">nach EN ISO 13485<\/strong> und mit dem Blick erfahrener Medizintechnik-Ingenieure.<\/p><h3 class=\"\">Warum eine unabh\u00e4ngige Pr\u00fcfung der Fertigungsunterlagen entscheidend ist?<\/h3><p data-end=\"1283\" data-start=\"1012\">In vielen Projekten zeigt sich: Zwischen Entwicklungsabschluss und Serienproduktion entstehen h\u00e4ufig L\u00fccken.<br data-start=\"1120\" data-end=\"1123\">Schnittstellen zwischen Entwicklung, Qualit\u00e4tssicherung und Produktion f\u00fchren schnell zu fehlenden oder uneinheitlichen Dokumenten \u2013 ein Risiko f\u00fcr jedes Audit.<\/p><p data-end=\"1343\" data-start=\"1285\"><strong data-end=\"1343\" data-start=\"1285\">Typische Stolperfallen in der Fertigungsdokumentation:<\/strong><\/p><ul class=\"\"><li data-end=\"1395\" data-start=\"1346\">Fehlende oder uneinheitliche Arbeitsanweisungen<\/li><li data-end=\"1457\" data-start=\"1398\">Nicht nachvollziehbare Versionsst\u00e4nde von Spezifikationen<\/li><li data-end=\"1520\" data-start=\"1460\">Unklare Pr\u00fcfkriterien oder fehlende Pr\u00fcfmitteldefinitionen<\/li><li data-end=\"1559\" data-start=\"1523\">FMEAs ohne aktuelle Prozessrisiken<\/li><li data-end=\"1611\" data-start=\"1562\">Nicht vollst\u00e4ndig validierte Fertigungsprozesse<\/li><\/ul><p>Diese Schwachstellen fallen oft erst im Audit auf \u2013 dann, wenn es teuer und zeitkritisch wird.<br data-start=\"1707\" data-end=\"1710\">Deshalb setzen wir fr\u00fcher an: Wir pr\u00fcfen Ihre Unterlagen, bevor die Produktion startet.<br><br><\/p><h2 data-end=\"1881\" data-start=\"1804\" class=\"\"><strong data-end=\"1881\" data-start=\"1807\">Der MEDtech Production-Ready-Report: Ihr Audit-Check f\u00fcr die Fertigung<\/strong><\/h2><p data-end=\"2237\" data-start=\"1883\">Im <strong data-end=\"1913\" data-start=\"1886\">Production-Ready-Report<\/strong> analysieren unsere Experten die Dokumente, die f\u00fcr eine reibungslose und regelkonforme Fertigung notwendig sind.<br data-start=\"2026\" data-end=\"2029\">Von Spezifikationen \u00fcber Arbeitsanweisungen bis hin zu FMEAs und Validierungen pr\u00fcfen wir, ob alle Inhalte vollst\u00e4ndig, aktuell und nachvollziehbar sind \u2013 mit Fokus auf die Anforderungen der <strong data-end=\"2236\" data-start=\"2220\">EN ISO 13485<\/strong>.<\/p><\/div><div data-inherit-lp-settings=\"1\" data-match-lp-colors=\"1\" class=\"thrv_wrapper thrv-page-section tve-height-update tcb-local-vars-root\" data-css=\"tve-u-197c539c528\" style=\"\" tcb-template-name=\"Benefits 03\" tcb-template-id=\"65a7f75a6ee2fefacc037ad2\" data-keep-css_id=\"1\" data-form-settings=\"__TCB_FORM__{&quot;form_identifier&quot;:&quot;-form-t9e1yk&quot;}__TCB_FORM__\"><div class=\"thrive-group-edit-config\" style=\"display: none !important\">__CONFIG_group_edit__{\"lrhya2v0\":{\"name\":\"List Icon\",\"singular\":\"-- Icon %s\"},\"lrhyabr7\":{\"name\":\"List Title\",\"singular\":\"-- Text %s\"},\"lrhyakpw\":{\"name\":\"List Text\",\"singular\":\"-- Text %s\"},\"lrhyav2f\":{\"name\":\"Benefit Box\",\"singular\":\"-- Content Box %s\"},\"lrhyb910\":{\"name\":\"Benefit Column\",\"singular\":\"-- Column %s\"},\"lrhybh8z\":{\"name\":\"Benefit Columns\",\"singular\":\"-- Columns %s\"}}__CONFIG_group_edit__<\/div><div class=\"thrive-local-colors-config\" style=\"display: none !important\">__CONFIG_local_colors__{\"colors\":{\"--tcb-skin-color-32\":\"Wild Sand\",\"--tcb-skin-color-0\":\"Azure Radiance\"},\"gradients\":{}}__CONFIG_local_colors__<\/div>\n\t<div class=\"tve-page-section-out\" style=\"\" data-css=\"tve-u-197c539c52d\"><\/div>\n\t<div class=\"tve-page-section-in   tve_empty_dropzone\" style=\"\" data-css=\"tve-u-197c539c529\"><div class=\"thrv_wrapper thrv-columns\" style=\"--tcb-col-el-width: 900;\"><div class=\"tcb-flex-row v-2 tcb-medium-wrap tcb-row-reversed-tablet tcb--cols--1\" data-css=\"tve-u-197c539c52b\" style=\"\"><div class=\"tcb-flex-col\" style=\"\" data-css=\"tve-u-197c539c535\"><div class=\"tcb-col\" style=\"\" data-css=\"tve-u-197c539c534\"><div class=\"tcb-clear\" data-css=\"tve-u-197c5486776\"><div class=\"thrv_wrapper thrv_contentbox_shortcode thrv-content-box tve-elem-default-pad\" data-css=\"tve-u-197c539c533\" style=\"\">\n\t<div class=\"tve-content-box-background\"><\/div>\n\t<div class=\"tve-cb\"><div class=\"tcb-clear\" data-css=\"tve-u-197c5483097\"><div class=\"thrv_wrapper thrv_text_element tcb-mobile-hidden\" data-css=\"tve-u-197c539c52c\" style=\"\"><h1 class=\"\" data-css=\"tve-u-197c539c536\">So l\u00e4uft der prozess ab<\/h1><\/div><\/div><div class=\"tcb-clear\" data-css=\"tve-u-197c5483097\"><div class=\"thrv_wrapper thrv_text_element tcb-tablet-hidden tcb-desktop-hidden\" data-css=\"tve-u-197c55a6094\" style=\"\"><h1 class=\"\" data-css=\"tve-u-197c55ba626\" style=\"\">Der Production Ready Report<\/h1><\/div><\/div><\/div>\n<\/div><\/div><div class=\"thrv_wrapper thrv_toggle\" data-columns=\"1\" data-animation=\"slide-fade\" data-animation-speed=\"slow\" data-ct-name=\"Default\" data-ct=\"toggle-55351\" data-css=\"tve-u-197c539c537\" style=\"\">\n\t<div class=\"tve-toggle-grid tve-prevent-content-edit\" style=\"\"><div class=\"tve-toggle-column\" data-index=\"1\" style=\"\"><div class=\"thrv_toggle_item tve_faq tve-default-state-expanded\">\n\t\t\t\t<div class=\"tve_faqI\">\n\t\t\t\t\t<div class=\"tve_faqB thrv_toggle_title tve-toggle-show-icon tcb-icon-display\" data-icon-code=\"icon-check-solid\" data-css=\"tve-u-17010f7948c\" data-selector=\"[data-css=&quot;tve-u-197c539c537&quot;] .thrv_toggle_title\" data-tcb_hover_state_parent=\"\" style=\"\">\n\t\t\t\t\t\t<div class=\"tve_toggle\" style=\"\"><svg class=\"tcb-icon\" viewBox=\"0 0 448 512\" data-id=\"icon-check-solid\" data-name=\"\"><!--! Font Awesome Free 6.7.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license\/free (Icons: CC BY 4.0, Fonts: SIL OFL 1.1, Code: MIT License) Copyright 2024 Fonticons, Inc. --><path d=\"M438.6 105.4c12.5 12.5 12.5 32.8 0 45.3l-256 256c-12.5 12.5-32.8 12.5-45.3 0l-128-128c-12.5-12.5-12.5-32.8 0-45.3s32.8-12.5 45.3 0L160 338.7 393.4 105.4c12.5-12.5 32.8-12.5 45.3 0z\"><\/path><\/svg><\/div>\n\t\t\t\t\t\t<h4 class=\"tve-toggle-text\" style=\"\">Onboarding &amp; NDA (Non disclosure agreement)<\/h4>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div class=\"tve_faqC \">\n\t\t\t\t\t\t<div class=\"thrv_wrapper thrv_toggle_content tve-elem-default-pad\" data-css=\"tve-u-197c539c538\" style=\"\">\n\t\t\t\t\t\t\t<div class=\"tve-content-box-background\" data-css=\"tve-u-17010f7948f\"><\/div>\n\t\t\t\t\t\t\t<div class=\"tve-cb\">\n\t\t\t\t\t\t\t\t<div class=\"thrv_wrapper thrv_text_element\" style=\"\" data-css=\"tve-u-197c539c53e\"><p data-css=\"tve-u-197c539c53c\" style=\"text-align: left;\">Nach einem ersten Gespr\u00e4ch und der Unterzeichnung eines <strong data-end=\"2397\" data-start=\"2362\">Non Disclosure Agreements (NDA)<\/strong> stellen wir sicher, dass alle Informationen und Unterlagen vertraulich behandelt werden \u2013 verl\u00e4sslicher Datenschutz ist die Grundlage jeder Zusammenarbeit.\t\t\t\t\t\t\t\t<\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div><div class=\"thrv_toggle_item tve_faq\">\n\t\t\t\t<div class=\"tve_faqI\">\n\t\t\t\t\t<div class=\"tve_faqB thrv_toggle_title tve-toggle-show-icon tcb-icon-display\" data-icon-code=\"icon-check-solid\" data-css=\"tve-u-17010f7948c\" data-selector=\"[data-css=&quot;tve-u-197c539c537&quot;] .thrv_toggle_title\" data-tcb_hover_state_parent=\"\" style=\"\">\n\t\t\t\t\t\t<div class=\"tve_toggle\" style=\"\"><svg class=\"tcb-icon\" viewBox=\"0 0 448 512\" data-id=\"icon-check-solid\" data-name=\"\"><!--! Font Awesome Free 6.7.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license\/free (Icons: CC BY 4.0, Fonts: SIL OFL 1.1, Code: MIT License) Copyright 2024 Fonticons, Inc. --><path d=\"M438.6 105.4c12.5 12.5 12.5 32.8 0 45.3l-256 256c-12.5 12.5-32.8 12.5-45.3 0l-128-128c-12.5-12.5-12.5-32.8 0-45.3s32.8-12.5 45.3 0L160 338.7 393.4 105.4c12.5-12.5 32.8-12.5 45.3 0z\"><\/path><\/svg><\/div>\n\t\t\t\t\t\t<h4 class=\"tve-toggle-text\" style=\"\">Sicherer Upload Ihrer Fertigungsdokumente<\/h4>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div class=\"tve_faqC\">\n\t\t\t\t\t\t<div class=\"thrv_wrapper thrv_toggle_content tve-elem-default-pad\" data-css=\"tve-u-197c539c539\" style=\"\">\n\t\t\t\t\t\t\t<div class=\"tve-content-box-background\" data-css=\"tve-u-17010f7948f\"><\/div>\n\t\t\t\t\t\t\t<div class=\"tve-cb\">\n\t\t\t\t\t\t\t\t<div class=\"thrv_wrapper thrv_text_element\" style=\"\" data-css=\"tve-u-197c539c53f\"><p style=\"\" data-css=\"tve-u-197c539c53d\"><span style=\"font-size: 16px !important;\" data-css=\"tve-u-197c5402cdc\">Ihre aktuellen Fertigungsunterlagen werden verschl\u00fcsselt in unsere Cloud hochgeladen.<br data-start=\"2694\" data-end=\"2697\">Damit k\u00f6nnen wir eine strukturierte, effiziente und sichere Analyse starten \u2013 von Spezifikationen \u00fcber Pr\u00fcfanweisungen bis hin zu Validierungsunterlagen.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div><div class=\"thrv_toggle_item tve_faq\">\n\t\t\t\t<div class=\"tve_faqI\">\n\t\t\t\t\t<div class=\"tve_faqB thrv_toggle_title tve-toggle-show-icon tcb-icon-display\" data-icon-code=\"icon-check-solid\" data-css=\"tve-u-17010f7948c\" data-selector=\"[data-css=&quot;tve-u-197c539c537&quot;] .thrv_toggle_title\" data-tcb_hover_state_parent=\"\" style=\"\">\n\t\t\t\t\t\t<div class=\"tve_toggle\" style=\"\"><svg class=\"tcb-icon\" viewBox=\"0 0 448 512\" data-id=\"icon-check-solid\" data-name=\"\"><!--! Font Awesome Free 6.7.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license\/free (Icons: CC BY 4.0, Fonts: SIL OFL 1.1, Code: MIT License) Copyright 2024 Fonticons, Inc. --><path d=\"M438.6 105.4c12.5 12.5 12.5 32.8 0 45.3l-256 256c-12.5 12.5-32.8 12.5-45.3 0l-128-128c-12.5-12.5-12.5-32.8 0-45.3s32.8-12.5 45.3 0L160 338.7 393.4 105.4c12.5-12.5 32.8-12.5 45.3 0z\"><\/path><\/svg><\/div>\n\t\t\t\t\t\t<h4 class=\"tve-toggle-text\" style=\"\">Pr\u00fcfung durch unsere Fertigungsexperten<\/h4>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div class=\"tve_faqC\">\n\t\t\t\t\t\t<div class=\"thrv_wrapper thrv_toggle_content tve-elem-default-pad\" data-css=\"tve-u-197c539c53a\" style=\"\">\n\t\t\t\t\t\t\t<div class=\"tve-content-box-background\" data-css=\"tve-u-17010f7948f\"><\/div>\n\t\t\t\t\t\t\t<div class=\"tve-cb\">\n\t\t\t\t\t\t\t\t<div class=\"thrv_wrapper thrv_text_element\" style=\"\" data-css=\"tve-u-197c539c540\"><p data-css=\"tve-u-197c539c541\" style=\"\"><span style=\"font-size: 16px !important;\" data-css=\"tve-u-197c5412f5f\">Unsere Ingenieure pr\u00fcfen Ihre Dokumente auf Vollst\u00e4ndigkeit, Nachvollziehbarkeit und Audit-Tauglichkeit.<br data-start=\"3008\" data-end=\"3011\">Dabei identifizieren wir L\u00fccken, Inkonsistenzen oder Risiken, die eine reibungslose Produktion gef\u00e4hrden k\u00f6nnten.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div><div class=\"thrv_toggle_item tve_faq\">\n\t\t\t\t<div class=\"tve_faqI\">\n\t\t\t\t\t<div class=\"tve_faqB thrv_toggle_title tve-toggle-show-icon tcb-icon-display\" data-icon-code=\"icon-check-solid\" data-css=\"tve-u-17010f7948c\" data-selector=\"[data-css=&quot;tve-u-197c539c537&quot;] .thrv_toggle_title\" data-tcb_hover_state_parent=\"\" style=\"\">\n\t\t\t\t\t\t<div class=\"tve_toggle\" style=\"\"><svg class=\"tcb-icon\" viewBox=\"0 0 448 512\" data-id=\"icon-check-solid\" data-name=\"\"><!--! Font Awesome Free 6.7.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license\/free (Icons: CC BY 4.0, Fonts: SIL OFL 1.1, Code: MIT License) Copyright 2024 Fonticons, Inc. --><path d=\"M438.6 105.4c12.5 12.5 12.5 32.8 0 45.3l-256 256c-12.5 12.5-32.8 12.5-45.3 0l-128-128c-12.5-12.5-12.5-32.8 0-45.3s32.8-12.5 45.3 0L160 338.7 393.4 105.4c12.5-12.5 32.8-12.5 45.3 0z\"><\/path><\/svg><\/div>\n\t\t\t\t\t\t<h4 class=\"tve-toggle-text\" style=\"\">Erstellung des Production-Ready-Report<\/h4>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div class=\"tve_faqC\">\n\t\t\t\t\t\t<div class=\"thrv_wrapper thrv_toggle_content tve-elem-default-pad\" data-css=\"tve-u-197c539c53b\" style=\"\">\n\t\t\t\t\t\t\t<div class=\"tve-content-box-background\" data-css=\"tve-u-17010f7948f\"><\/div>\n\t\t\t\t\t\t\t<div class=\"tve-cb\">\n\t\t\t\t\t\t\t\t<div class=\"thrv_wrapper thrv_text_element\" style=\"\" data-css=\"tve-u-197c539c545\"><p style=\"\" data-css=\"tve-u-197c539c544\"><span style=\"font-size: 16px !important;\" data-css=\"tve-u-197c542078a\">Sie erhalten einen <strong data-end=\"3221\" data-start=\"3197\">detaillierten Report<\/strong> mit klarer Bewertung Ihres Production Readiness Levels.<br data-start=\"3277\" data-end=\"3280\">Der Bericht zeigt \u00fcbersichtlich, wo Sie bereits auditbereit sind \u2013 und wo Nachbesserungsbedarf besteht.<\/span> \t\t\t\t\t\t\t\t<\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div><div class=\"thrv_toggle_item tve_faq\">\n\t\t\t\t<div class=\"tve_faqI\">\n\t\t\t\t\t<div class=\"tve_faqB thrv_toggle_title tve-toggle-show-icon tcb-icon-display\" data-icon-code=\"icon-check-solid\" data-css=\"tve-u-17010f7948c\" data-selector=\"[data-css=&quot;tve-u-197c539c537&quot;] .thrv_toggle_title\" data-tcb_hover_state_parent=\"\" style=\"\">\n\t\t\t\t\t\t<div class=\"tve_toggle\" style=\"\"><svg class=\"tcb-icon\" viewBox=\"0 0 448 512\" data-id=\"icon-check-solid\" data-name=\"\"><!--! Font Awesome Free 6.7.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license\/free (Icons: CC BY 4.0, Fonts: SIL OFL 1.1, Code: MIT License) Copyright 2024 Fonticons, Inc. --><path d=\"M438.6 105.4c12.5 12.5 12.5 32.8 0 45.3l-256 256c-12.5 12.5-32.8 12.5-45.3 0l-128-128c-12.5-12.5-12.5-32.8 0-45.3s32.8-12.5 45.3 0L160 338.7 393.4 105.4c12.5-12.5 32.8-12.5 45.3 0z\"><\/path><\/svg><\/div>\n\t\t\t\t\t\t<h4 class=\"tve-toggle-text\" style=\"\">Abschlussgespr\u00e4ch &amp; Handlungsempfehlungen<\/h4>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div class=\"tve_faqC\">\n\t\t\t\t\t\t<div class=\"thrv_wrapper thrv_toggle_content tve-elem-default-pad\" data-css=\"tve-u-197c539c53b\" style=\"\">\n\t\t\t\t\t\t\t<div class=\"tve-content-box-background\" data-css=\"tve-u-17010f7948f\"><\/div>\n\t\t\t\t\t\t\t<div class=\"tve-cb\">\n\t\t\t\t\t\t\t\t<div class=\"thrv_wrapper thrv_text_element\" style=\"\" data-css=\"tve-u-197c539c545\"><p style=\"\" data-css=\"tve-u-197c539c544\"><span style=\"font-size: 16px !important;\" data-css=\"tve-u-197c542615c\">In einem finalen Gespr\u00e4ch erl\u00e4utern wir die Ergebnisse, besprechen konkrete Handlungsempfehlungen und zeigen auf Wunsch, wie Sie die L\u00fccken effizient schlie\u00dfen k\u00f6nnen.<br data-start=\"3606\" data-end=\"3609\">Auf Wunsch begleiten wir Sie auch bei der Umsetzung \u2013 bis zur erfolgreichen Fertigungseinf\u00fchrung.<\/span> \t\t\t\t\t\t\t\t<\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div><\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>\n<\/div><div class=\"thrv_wrapper thrv-button thrv-button-v2 tcb-local-vars-root\" data-css=\"tve-u-197c535ae21\" style=\"\">\n\t<div class=\"thrive-colors-palette-config\" style=\"display: none !important\">__CONFIG_colors_palette__{\"active_palette\":0,\"config\":{\"colors\":{\"62516\":{\"name\":\"Main Accent\",\"parent\":-1}},\"gradients\":[]},\"palettes\":[{\"name\":\"Default Palette\",\"value\":{\"colors\":{\"62516\":{\"val\":\"var(--tcb-skin-color-0)\"}},\"gradients\":[]}}]}__CONFIG_colors_palette__<\/div>\n\t<a href=\"https:\/\/medtech-ingenieur.de\/kontakt\/\" class=\"tcb-button-link tcb-plain-text\" target=\"_blank\">\n\t\t<span class=\"tcb-button-texts\"><span class=\"tcb-button-text thrv-inline-text\"><strong>Production-Ready-Report anfordern<\/strong><\/span><\/span>\n\t<\/a>\n<\/div><div class=\"thrv_wrapper thrv_text_element\"><h2 data-end=\"3748\" data-start=\"3713\" class=\"\"><strong data-end=\"3748\" data-start=\"3716\">Ihr Mehrwert auf einen Blick<\/strong><\/h2><\/div><div class=\"thrv_wrapper thrv-styled_list\" data-icon-code=\"icon-check\" data-css=\"tve-u-19a39dd9a66\" style=\"\"><ul class=\"tcb-styled-list\"><li class=\"thrv-styled-list-item\" data-css=\"tve-u-19a39dc90af\"><div class=\"tcb-styled-list-icon\"><div class=\"thrv_wrapper thrv_icon tve_no_drag tcb-no-delete tcb-no-clone tcb-no-save tcb-icon-inherit-style tcb-local-vars-root\" data-css=\"tve-u-19a39dd2ce5\" style=\"\"><svg class=\"tcb-icon tcb-local-vars-root\" viewBox=\"0 0 32 32\" data-id=\"icon-check\" data-name=\"\" style=\"\"><path d=\"M29.333 10.267c0 0.4-0.133 0.8-0.533 1.2l-14.8 14.8c-0.267 0.267-0.667 0.4-1.067 0.4s-0.933-0.133-1.2-0.533l-2.4-2.267-6.267-6.267c-0.267-0.267-0.4-0.667-0.4-1.2s0.133-0.8 0.533-1.2l2.4-2.4c0.267-0.133 0.667-0.4 1.067-0.4s0.8 0.133 1.2 0.533l5.067 5.067 11.2-11.333c0.267-0.267 0.667-0.533 1.2-0.533 0.4 0 0.8 0.133 1.2 0.533l2.4 2.4c0.267 0.267 0.4 0.667 0.4 1.2z\"><\/path><\/svg><\/div><\/div><span class=\"thrv-advanced-inline-text tve_editable tcb-styled-list-icon-text tcb-no-delete tcb-no-save\" data-css=\"tve-u-19a39dc4e06\" style=\"\">Sicherheit f\u00fcr interne und externe Audits<\/span><\/li><li class=\"thrv-styled-list-item\" data-css=\"tve-u-19a39dc90af\"><div class=\"tcb-styled-list-icon\"><div class=\"thrv_wrapper thrv_icon tve_no_drag tcb-no-delete tcb-no-clone tcb-no-save tcb-icon-inherit-style tcb-local-vars-root\" data-css=\"tve-u-19a39dd2ce5\" style=\"\"><svg class=\"tcb-icon tcb-local-vars-root\" viewBox=\"0 0 32 32\" data-id=\"icon-check\" data-name=\"\" style=\"\"><path d=\"M29.333 10.267c0 0.4-0.133 0.8-0.533 1.2l-14.8 14.8c-0.267 0.267-0.667 0.4-1.067 0.4s-0.933-0.133-1.2-0.533l-2.4-2.267-6.267-6.267c-0.267-0.267-0.4-0.667-0.4-1.2s0.133-0.8 0.533-1.2l2.4-2.4c0.267-0.133 0.667-0.4 1.067-0.4s0.8 0.133 1.2 0.533l5.067 5.067 11.2-11.333c0.267-0.267 0.667-0.533 1.2-0.533 0.4 0 0.8 0.133 1.2 0.533l2.4 2.4c0.267 0.267 0.4 0.667 0.4 1.2z\"><\/path><\/svg><\/div><\/div><span class=\"thrv-advanced-inline-text tve_editable tcb-styled-list-icon-text tcb-no-delete tcb-no-save\" data-css=\"tve-u-19a39dc4e06\" style=\"\">Klarheit \u00fcber den Status Ihrer Fertigungsunterlagen<\/span><\/li><li class=\"thrv-styled-list-item\" data-css=\"tve-u-19a39dc90af\"><div class=\"tcb-styled-list-icon\"><div class=\"thrv_wrapper thrv_icon tve_no_drag tcb-no-delete tcb-no-clone tcb-no-save tcb-icon-inherit-style tcb-local-vars-root\" data-css=\"tve-u-19a39dd2ce5\" style=\"\"><svg class=\"tcb-icon tcb-local-vars-root\" viewBox=\"0 0 32 32\" data-id=\"icon-check\" data-name=\"\" style=\"\"><path d=\"M29.333 10.267c0 0.4-0.133 0.8-0.533 1.2l-14.8 14.8c-0.267 0.267-0.667 0.4-1.067 0.4s-0.933-0.133-1.2-0.533l-2.4-2.267-6.267-6.267c-0.267-0.267-0.4-0.667-0.4-1.2s0.133-0.8 0.533-1.2l2.4-2.4c0.267-0.133 0.667-0.4 1.067-0.4s0.8 0.133 1.2 0.533l5.067 5.067 11.2-11.333c0.267-0.267 0.667-0.533 1.2-0.533 0.4 0 0.8 0.133 1.2 0.533l2.4 2.4c0.267 0.267 0.4 0.667 0.4 1.2z\"><\/path><\/svg><\/div><\/div><span class=\"thrv-advanced-inline-text tve_editable tcb-styled-list-icon-text tcb-no-delete tcb-no-save\" data-css=\"tve-u-19a39dc4e06\" style=\"\">\u00dcbersichtliche Bewertung und konkrete To-dos<\/span><\/li><li class=\"thrv-styled-list-item\" data-css=\"tve-u-19a39dc90af\"><div class=\"tcb-styled-list-icon\"><div class=\"thrv_wrapper thrv_icon tve_no_drag tcb-no-delete tcb-no-clone tcb-no-save tcb-icon-inherit-style tcb-local-vars-root\" data-css=\"tve-u-19a39dd2ce5\" style=\"\"><svg class=\"tcb-icon tcb-local-vars-root\" viewBox=\"0 0 32 32\" data-id=\"icon-check\" data-name=\"\" style=\"\"><path d=\"M29.333 10.267c0 0.4-0.133 0.8-0.533 1.2l-14.8 14.8c-0.267 0.267-0.667 0.4-1.067 0.4s-0.933-0.133-1.2-0.533l-2.4-2.267-6.267-6.267c-0.267-0.267-0.4-0.667-0.4-1.2s0.133-0.8 0.533-1.2l2.4-2.4c0.267-0.133 0.667-0.4 1.067-0.4s0.8 0.133 1.2 0.533l5.067 5.067 11.2-11.333c0.267-0.267 0.667-0.533 1.2-0.533 0.4 0 0.8 0.133 1.2 0.533l2.4 2.4c0.267 0.267 0.4 0.667 0.4 1.2z\"><\/path><\/svg><\/div><\/div><span class=\"thrv-advanced-inline-text tve_editable tcb-styled-list-icon-text tcb-no-delete tcb-no-save\" data-css=\"tve-u-19a39dc4e06\" style=\"\">Normgerechte Analyse nach EN ISO 13485<\/span><\/li><li class=\"thrv-styled-list-item\" data-css=\"tve-u-19a39dc90af\"><div class=\"tcb-styled-list-icon\"><div class=\"thrv_wrapper thrv_icon tve_no_drag tcb-no-delete tcb-no-clone tcb-no-save tcb-icon-inherit-style tcb-local-vars-root\" data-css=\"tve-u-19a39dd2ce5\" style=\"\"><svg class=\"tcb-icon tcb-local-vars-root\" viewBox=\"0 0 32 32\" data-id=\"icon-check\" data-name=\"\" style=\"\"><path d=\"M29.333 10.267c0 0.4-0.133 0.8-0.533 1.2l-14.8 14.8c-0.267 0.267-0.667 0.4-1.067 0.4s-0.933-0.133-1.2-0.533l-2.4-2.267-6.267-6.267c-0.267-0.267-0.4-0.667-0.4-1.2s0.133-0.8 0.533-1.2l2.4-2.4c0.267-0.133 0.667-0.4 1.067-0.4s0.8 0.133 1.2 0.533l5.067 5.067 11.2-11.333c0.267-0.267 0.667-0.533 1.2-0.533 0.4 0 0.8 0.133 1.2 0.533l2.4 2.4c0.267 0.267 0.4 0.667 0.4 1.2z\"><\/path><\/svg><\/div><\/div><span class=\"thrv-advanced-inline-text tve_editable tcb-styled-list-icon-text tcb-no-delete tcb-no-save\" data-css=\"tve-u-19a39dc4e06\" style=\"\">Fachliche Unterst\u00fctzung durch erfahrene MedTech-Ingenieure<\/span><\/li><\/ul><\/div><div class=\"thrv_wrapper thrv_text_element\"><p><br><\/p><h2 data-end=\"4069\" data-start=\"4012\" class=\"\"><strong data-end=\"4069\" data-start=\"4015\">Praxisbeispiel: Serienfreigabe ohne \u00dcberraschungen<\/strong><\/h2><p data-end=\"4314\" data-start=\"4071\">Ein Kunde stand kurz vor der Serienfreigabe seines neuen Medizinger\u00e4ts.<br data-start=\"4142\" data-end=\"4145\">Bei der internen Pr\u00fcfung zeigte sich, dass mehrere Validierungsnachweise fehlten und einige Arbeitsanweisungen nicht mit den aktuellen Spezifikationen \u00fcbereinstimmten.<\/p><p data-end=\"4559\" data-start=\"4316\">Innerhalb weniger Tage haben wir alle Unterlagen gesichtet, L\u00fccken aufgezeigt und Empfehlungen zur Nachdokumentation gegeben.<br data-start=\"4441\" data-end=\"4444\">Das Ergebnis: Die Serienfreigabe erfolgte ohne Beanstandung \u2013 und der Kunde startete p\u00fcnktlich in die Produktion.<\/p><h2 data-end=\"4602\" data-start=\"4566\" class=\"\"><strong data-end=\"4602\" data-start=\"4569\">Jetzt Production Ready werden<\/strong><\/h2><\/div><div class=\"thrv_wrapper thrv_text_element\"><p data-end=\"4773\" data-start=\"4604\">Sie m\u00f6chten wissen, ob Ihre Produktionsdokumentation wirklich audit-tauglich ist?<br data-start=\"4685\" data-end=\"4688\">Dann starten Sie mit einem kostenlosen Erstgespr\u00e4ch mit unseren Fertigungsexperten oder sehen Sie sich unser gesamtes Dienstleistungsportfolio f\u00fcr <span style=\"color: var(--tcb-skin-color-2) !important;\" data-css=\"tve-u-19a6d130efc\"><a href=\"https:\/\/medtech-ingenieur.de\/auftragsfertigung-medizintechnik\/\" target=\"_blank\" class=\"\" style=\"outline: none;\"><span style=\"--tcb-applied-color: var$(--tcb-skin-color-2) !important;\" data-css=\"tve-u-19a6d130efe\">Produktion &amp; Fertigung<\/span><\/a><\/span> an.<\/p><p data-end=\"4890\" data-start=\"4775\">Gemeinsam bringen wir Ihre Fertigung <strong data-end=\"4888\" data-start=\"4815\">auf den Punkt \u2013 audit-sicher, effizient und ready f\u00fcr die Produktion.<\/strong><\/p><\/div><div class=\"thrv_wrapper thrv-button thrv-button-v2 tcb-local-vars-root\" data-css=\"tve-u-19a3a2ddc2d\">\n\t<div class=\"thrive-colors-palette-config\" style=\"display: none !important\">__CONFIG_colors_palette__{\"active_palette\":0,\"config\":{\"colors\":{\"62516\":{\"name\":\"Main Accent\",\"parent\":-1}},\"gradients\":[]},\"palettes\":[{\"name\":\"Default Palette\",\"value\":{\"colors\":{\"62516\":{\"val\":\"var(--tcb-skin-color-0)\"}},\"gradients\":[]}}]}__CONFIG_colors_palette__<\/div>\n\t<a href=\"https:\/\/medtech-ingenieur.de\/kontakt\/\" class=\"tcb-button-link tcb-plain-text\">\n\t\t<span class=\"tcb-button-texts\"><span class=\"tcb-button-text thrv-inline-text\">Jetzt unverbindlich anfragen<\/span><\/span>\n\t<\/a>\n<\/div>","tve_custom_css":"@import url(\"\/\/fonts.googleapis.com\/css?family=Montserrat:400,700,900&subset=latin\");@media (min-width: 300px){.tcb-post-list[data-css=\"tve-u-18d31773283\"] .post-wrapper.thrv_wrapper { width: 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GmbH<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/medtech-ingenieur.de\/en\/medizintechnik-fertigungsunterlagen-pruefen\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fertigungsunterlagen in der Medizintechnik - MEDtech Ingenieur GmbH\" \/>\n<meta property=\"og:description\" content=\"So pr\u00fcfen Sie Ihre Produktionsdokumentation auf Audit-Tauglichkeit Wenn die Produktion startet, ist es zu sp\u00e4t f\u00fcr Unsicherheiten in der Dokumentation.Ein fehlendes Pr\u00fcfprotokoll, eine unklare Arbeitsanweisung oder eine unvollst\u00e4ndige FMEA \u2013 und schon steht das Audit oder die Serienfreigabe auf der Kippe. 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