{"id":6420,"date":"2026-06-02T14:23:00","date_gmt":"2026-06-02T13:23:00","guid":{"rendered":"https:\/\/compozer.test\/medical-devices\/"},"modified":"2026-07-01T10:26:30","modified_gmt":"2026-07-01T09:26:30","slug":"medical-devices","status":"publish","type":"page","link":"https:\/\/xibis.nl\/en\/industries\/medical-devices\/","title":{"rendered":"Medical Devices"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":6423,"menu_order":21,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6420","page","type-page","status-publish","hentry"],"acf":{"flexible_content":[{"acf_fc_layout":"image_full_width","title":"Accelerate digital transformation in Medical Devices <svg width=\"22\" height=\"40\" viewBox=\"0 0 22 40\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"> <path d=\"M0 0H10.543L22 20L10.543 40H0L11.4569 20L0 0Z\" fill=\"#B79C5F\"\/> <\/svg>","text":"Industry-specific ERP for FDA, EU MDR, and ISO 13485 compliance","buttons":[{"link":{"title":"Free Strategy Consultation","url":"https:\/\/xibis.nl\/en\/non-binding-strategy-conversation\/","target":"","class":"primary"}}],"media":{"choice":"image","toggle":true,"chosen_element":"4999","attributes":{"horizontal":"right","vertical":"bottom","custom_style_element_size":true,"min_element_size":"","style_element_size":100,"max_element_size":""},"image":"{\"original_image\":\"6060\",\"cropped_image\":\"6060\"}","platform":"vimeo","autoplay_toggle":false,"vimeo":"","youtube":"","upload_video_file":null},"layout_text_align":"left","color_overlay":"rgba(0,0,0,0.2)","heading_type":"h1","heading":"h1","padding":{"top":"0","bottom":"0"},"image-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"layout_custom_css":".layout# .layout__container {\r\n  max-height: 100vh;\r\n}\r\n.layout# .cmpzr-image__src {\r\n  object-position: bottom right;\r\n}"},{"acf_fc_layout":"wysiwyg","pre_title":"","title":"","intro":"","content":"Manufacturers of medical devices operate under the strictest regulations in the world. ISO 13485, FDA QMSR (as of February 2026), 21 CFR Part 11, and EU MDR require validated processes, audit trails, and complete traceability. Infor CloudSuite is industry-specific for medical devices.\r\n<h2>Your challenges<\/h2>\r\n<ul>\r\n \t<li><strong>Strict regulations and validation.<\/strong> Validated processes, audit trails, and electronic signatures are a requirement.<\/li>\r\n \t<li><strong>Cradle-to-grave traceability and UDI.<\/strong> Every device uniquely identifiable (UDI-DI\/UDI-PI), with DHR and DMR.<\/li>\r\n \t<li><strong>Rigorous change control.<\/strong> Every change processed via formal change requests, impact assessments, and revalidation.<\/li>\r\n \t<li><strong>Innovation speed versus regulation.<\/strong> Short post-launch product life cycles clash with conservative regulations.<\/li>\r\n \t<li><strong>Pressure on cost and sustainability.<\/strong> Hospitals demand recyclable packaging and PCR content at lower prices.<\/li>\r\n<\/ul>\r\n<h2>Our industry-specific solution<\/h2>\r\nXibis delivers an industry-specific, validatable environment for medical device manufacturers with Infor CloudSuite:\r\n<ul>\r\n \t<li><strong>Cradle-to-grave traceability and UDI.<\/strong> Lot and serial tracking including UDI-DI\/UDI-PI, recall scenarios executable in minutes.<\/li>\r\n \t<li><strong>Electronic DHR and DMR.<\/strong> Automated Device History Records with electronic signatures, compliant with 21 CFR Part 11.<\/li>\r\n \t<li><strong>Change control and validation as standard.<\/strong> Engineering change requests and revalidation workflows as core processes, not add-ons.<\/li>\r\n \t<li><strong>Integrated quality management.<\/strong> NCR, CAPA, supplier quality, and post-market surveillance on the same data as production.<\/li>\r\n \t<li><strong>Ready for FDA QMSR and EU MDR.<\/strong> One set of processes for both FDA and notified body audits in the EU.<\/li>\r\n<\/ul>\r\n<h2>Why Xibis<\/h2>\r\n<ul>\r\n \t<li><strong>Industry-specific for medical devices.<\/strong> Compliance, validation, and traceability are embedded, not bolted on.<\/li>\r\n \t<li><strong>Experience with validated implementations.<\/strong> We understand what IQ\/OQ\/PQ validation means for your ERP journey.<\/li>\r\n \t<li><strong>International regulatory coverage.<\/strong> FDA, EU MDR, MHRA, and PMDA on one platform.<\/li>\r\n<\/ul>","buttons":null,"heading_type":"h2","heading":"h2","layout_text_align":"left","layout_textbox_size":"10","text_color":"","padding":{"top":"m","bottom":"m"},"layout_bg_show_image":false,"background_color":"","layout_bg_overlay":"","layout_bg_image_desktop":null,"layout_bg_position_desktop":"center","layout_bg_image_mobile":null,"layout_bg_position_mobile":"center","pre-title-transition":{"has_transition":false,"transition_type":"none","transition_offset":0,"transition_delay":0},"title-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"intro-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"text-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"layout_custom_css":""},{"acf_fc_layout":"ctabanner","title":"Ready for FDA QMSR and EU MDR?","intro":"Schedule a strategy session with our medical device experts. We'll show you how a validated, industry-specific platform combines compliance and operational speed.","link":{"title":"Schedule your strategy session","url":"https:\/\/xibis.nl\/en\/non-binding-strategy-conversation\/","target":"","class":"primary"},"heading_type":"h2","heading":"h2","layout_background_image":"{\"original_image\":\"4922\",\"cropped_image\":5992}","background_color":"#b79c5f","text_color":"#ffffff","padding":{"top":"m","bottom":"m"},"title-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"intro-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"buttons-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"layout_custom_css":""},{"acf_fc_layout":"grid","pre_title":"","title":"Digitalization in Metal & Mechatronics: opportunities and challenges","intro":"Metal and mechatronics companies combine sheet metal and machining work, assembly and software. Customer-specific work and repeat series run on the same machines, while margins are under pressure and technical staff are scarce. Infor CloudSuite is industry-specific for this hybrid reality.","layout_columns":"three","layout_choice":"create","photo_format":"rectangle","show_readmore_link":true,"grid_post_select":null,"blocks":[{"image":"{\"original_image\":5006,\"cropped_image\":{\"image\":\"2026\/05\/Rectangle-5_x_acf_cropped.webp\",\"preview\":\"2026\/05\/preview_Rectangle-5_x_acf_cropped.webp\"}}","title":"Control over complex and diverse processes","intro":"Combine a mix of complex processes (ETO, CTO, ATO, MTO) in one smart ERP platform. With Infor CloudSuite you gain control over mix-mode production through seamless integration with CPQ (for sales configurations) and PLM (for engineering data). This allows you to manage all core processes \u2013 from quote to delivery and service \u2013 fully data-driven and process-controlled.","link":{"title":"Infor Cloudsuite","url":"https:\/\/xibis.nl\/en\/solutions\/enterprise-resource-planning-infor-erp-ln\/","target":""}},{"image":"{\"original_image\":5013,\"cropped_image\":{\"image\":\"2026\/05\/Rectangle-3_x_acf_cropped.jpg\",\"preview\":\"2026\/05\/preview_Rectangle-3_x_acf_cropped.jpg\"}}","title":"Configure quotes faster, smarter and error-free","intro":"Streamline the quoting process with Infor CPQ: flawlessly configure complex products with 2D and 3D visualizations and generate quotes including pricing and specifications at lightning speed. Everything directly integrated with your ERP, enabling you to accelerate sales, reduce costs and differentiate your brand with a unique customer experience.","link":{"title":"Infor CPQ","url":"https:\/\/xibis.nl\/en\/solutions\/configure-price-quote-infor-cpq\/","target":""}},{"image":"{\"original_image\":4973,\"cropped_image\":{\"image\":\"2026\/05\/Rectangle-2_x_acf_cropped.jpg\",\"preview\":\"2026\/05\/preview_Rectangle-2_x_acf_cropped.jpg\"}}","title":"Accelerate innovation with streamlined product lifecycle management","intro":"Infor PLM integrates design data with ERP and production processes, eliminating duplicate entry and centralizing version management. This gives you control over variants, BOMs, and changes at every stage of the product \u2013 from concept to delivery \u2013 and accelerates time-to-market with a single source of truth in data.","link":{"title":"Infor PLM","url":"https:\/\/xibis.nl\/en\/solutions\/product-lifecycle-management-infor-plm\/","target":""}},{"image":"{\"original_image\":4764,\"cropped_image\":{\"image\":\"2026\/05\/istockphoto-2206103905-1024x1024-1_x_acf_cropped.jpg\",\"preview\":\"2026\/05\/preview_istockphoto-2206103905-1024x1024-1_x_acf_cropped.jpg\"}}","title":"Digitize production and logistics: paperless and data-driven","intro":"Make floor operations smarter and faster by fully digitalizing production and warehouse processes. Infor Factory Track provides real-time insight into work orders, automatic inventory registration via barcode scanning, and streamlined processes for picking, packing, and shipping \u2013 without paper, errors, or delays.","link":{"title":"Infor Factory Track","url":"https:\/\/xibis.nl\/en\/solutions\/infor-factory-track\/","target":""}},{"image":"{\"original_image\":4780,\"cropped_image\":{\"image\":\"2026\/05\/istockphoto-1057719100-1024x1024-1_x_acf_cropped.jpg\",\"preview\":\"2026\/05\/preview_istockphoto-1057719100-1024x1024-1_x_acf_cropped.jpg\"}}","title":"Better decision-making and higher productivity with AI for manufacturing","intro":"Infor GenAI delivers real-time insights and recommendations at the right moment. By automating repetitive tasks and embedding AI within existing workflows, your team works faster, smarter, and with fewer errors \u2013 without losing time to searching or analyzing.","link":{"title":"Infor GenAI","url":"https:\/\/xibis.nl\/en\/solutions\/infor-genai\/","target":""}},{"image":"{\"original_image\":4934,\"cropped_image\":{\"image\":\"2026\/05\/getty-images-D7RmaEO2S4w-unsplash_x_acf_cropped.jpg\",\"preview\":\"2026\/05\/preview_getty-images-D7RmaEO2S4w-unsplash_x_acf_cropped.jpg\"}}","title":"Technological foundation for integration, data, and innovation","intro":"Infor OS is the smart foundation for integration, data access, and automation. You can easily connect applications and processes, automate workflows, and manage documents centrally. One platform for a flexible and scalable IT architecture, ready for digital growth and innovation.","link":{"title":"Infor OS","url":"https:\/\/xibis.nl\/en\/solutions\/integrations-infor-os\/","target":""}}],"heading_type":"h2","heading":"h2","layout_text_align":"left","text_color":"","block_styling":{"hover_shadow":true,"block_outline":true},"grid_slider":false,"grid_slider_width":"container","grid_slider_slides":"3","grid_slider_nav":true,"grid_slider_pagination":false,"grid_slider_autoplay":false,"grid_slider_delay":2,"grid_slider_loop":false,"padding":{"top":"m","bottom":"m"},"layout_bg_show_image":false,"background_color":"","layout_bg_overlay":"","layout_bg_image_desktop":null,"layout_bg_position_desktop":"center","layout_bg_image_mobile":null,"layout_bg_position_mobile":"center","pre-title-transition":{"has_transition":false,"transition_type":"none","transition_offset":0,"transition_delay":0},"title-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"intro-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"text-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"layout_custom_css":""},{"acf_fc_layout":"global_layout","global_layout":6570},{"acf_fc_layout":"global_layout","global_layout":6573},{"acf_fc_layout":"global_layout","global_layout":6571},{"acf_fc_layout":"collection","pre_title":"","title":"Insights for the manufacturing industry","intro":"","select_post_type":"post","xibis_style":false,"button":"","term_select":"show_all","select_terms":[],"number_posts":"3","post_order":"menu_order","show_categories":true,"show_filter":false,"type_filter":"","show_dates":false,"show_intro":true,"limit_blog":false,"show_pagination":false,"heading_type":"h2","heading":"h2","layout_text_align":"left","text_color":"#222222","block_styling":{"hover_shadow":true,"block_outline":true},"padding":{"top":"m","bottom":"m"},"layout_bg_show_image":false,"background_color":"#ffffff","layout_bg_overlay":"","layout_bg_image_desktop":null,"layout_bg_position_desktop":"center","layout_bg_image_mobile":null,"layout_bg_position_mobile":"center","pre-title-transition":{"has_transition":false,"transition_type":"none","transition_offset":0,"transition_delay":0},"title-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"text-transition":{"has_transition":false,"transition_type":"none","transition_offset":"","transition_delay":0},"layout_custom_css":""}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Devices | Xibis<\/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:\/\/xibis.nl\/en\/industries\/medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Devices | Xibis\" \/>\n<meta property=\"og:url\" content=\"https:\/\/xibis.nl\/en\/industries\/medical-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"Xibis\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-01T09:26:30+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/xibis.nl\\\/en\\\/industries\\\/medical-devices\\\/\",\"url\":\"https:\\\/\\\/xibis.nl\\\/en\\\/industries\\\/medical-devices\\\/\",\"name\":\"Medical Devices | Xibis\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/xibis.nl\\\/#website\"},\"datePublished\":\"2026-06-02T13:23:00+00:00\",\"dateModified\":\"2026-07-01T09:26:30+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/xibis.nl\\\/en\\\/industries\\\/medical-devices\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/xibis.nl\\\/en\\\/industries\\\/medical-devices\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/xibis.nl\\\/en\\\/industries\\\/medical-devices\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/xibis.nl\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Industries\",\"item\":\"https:\\\/\\\/xibis.nl\\\/en\\\/industries\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Medical Devices\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/xibis.nl\\\/#website\",\"url\":\"https:\\\/\\\/xibis.nl\\\/\",\"name\":\"Xibis\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/xibis.nl\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Medical Devices | Xibis","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/xibis.nl\/en\/industries\/medical-devices\/","og_locale":"en_US","og_type":"article","og_title":"Medical Devices | Xibis","og_url":"https:\/\/xibis.nl\/en\/industries\/medical-devices\/","og_site_name":"Xibis","article_modified_time":"2026-07-01T09:26:30+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/xibis.nl\/en\/industries\/medical-devices\/","url":"https:\/\/xibis.nl\/en\/industries\/medical-devices\/","name":"Medical Devices | Xibis","isPartOf":{"@id":"https:\/\/xibis.nl\/#website"},"datePublished":"2026-06-02T13:23:00+00:00","dateModified":"2026-07-01T09:26:30+00:00","breadcrumb":{"@id":"https:\/\/xibis.nl\/en\/industries\/medical-devices\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/xibis.nl\/en\/industries\/medical-devices\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/xibis.nl\/en\/industries\/medical-devices\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/xibis.nl\/en\/"},{"@type":"ListItem","position":2,"name":"Industries","item":"https:\/\/xibis.nl\/en\/industries\/"},{"@type":"ListItem","position":3,"name":"Medical Devices"}]},{"@type":"WebSite","@id":"https:\/\/xibis.nl\/#website","url":"https:\/\/xibis.nl\/","name":"Xibis","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/xibis.nl\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/xibis.nl\/en\/wp-json\/wp\/v2\/pages\/6420","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/xibis.nl\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/xibis.nl\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/xibis.nl\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/xibis.nl\/en\/wp-json\/wp\/v2\/comments?post=6420"}],"version-history":[{"count":3,"href":"https:\/\/xibis.nl\/en\/wp-json\/wp\/v2\/pages\/6420\/revisions"}],"predecessor-version":[{"id":6731,"href":"https:\/\/xibis.nl\/en\/wp-json\/wp\/v2\/pages\/6420\/revisions\/6731"}],"up":[{"embeddable":true,"href":"https:\/\/xibis.nl\/en\/wp-json\/wp\/v2\/pages\/6423"}],"wp:attachment":[{"href":"https:\/\/xibis.nl\/en\/wp-json\/wp\/v2\/media?parent=6420"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}