{"id":74650,"date":"2022-04-25T16:30:53","date_gmt":"2022-04-25T14:30:53","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/?page_id=74650"},"modified":"2025-03-19T07:26:07","modified_gmt":"2025-03-19T06:26:07","slug":"is-your-medical-device-software-ready-for-mdr","status":"publish","type":"page","link":"https:\/\/lightweb.dev\/s\/key2compliance\/is-your-medical-device-software-ready-for-mdr\/","title":{"rendered":"Is your Medical Device Software ready for MDR?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"74650\" class=\"elementor elementor-74650\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-452ae0f1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"452ae0f1\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wide\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-754034f8\" data-id=\"754034f8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-53d693d8 elementor-widget elementor-widget-heading\" data-id=\"53d693d8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Is your Medical Device Software  ready for MDR?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6e6d3181 elementor-widget elementor-widget-text-editor\" data-id=\"6e6d3181\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>The Medical Device Regulation (MDR) is fully applicable since May 26<sup>th<\/sup> 2021.<\/p><p>Although the MDR transitional provision has been extended* there is no time to lose for Medical Device Software manufacturers (MDSW) to be compliant with MDR since only then it is possible to continue updating and improving your software the way you want to (without considering the restrictions of MDR article 120).<\/p><p>We have the perfect package deal that will keep you ahead of the game and compliant with the requirements.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-21b26e44\" data-id=\"21b26e44\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6423689c elementor-widget elementor-widget-image\" data-id=\"6423689c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"768\" height=\"512\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/mdr-sw-860-bl-768x512.avif\" class=\"attachment-medium_large size-medium_large wp-image-104469\" alt=\"Medical icons over a smartphone\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/mdr-sw-860-bl-768x512.avif 768w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/mdr-sw-860-bl-300x200.avif 300w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/mdr-sw-860-bl-600x400.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/mdr-sw-860-bl.avif 860w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6ee9152 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6ee9152\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f46916f\" data-id=\"f46916f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5458cf7 elementor-widget elementor-widget-text-editor\" data-id=\"5458cf7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<span style=\"font-size: 10.0pt;\">* 31 December 2027, class III and IIb devices, 31 December 2028, class IIa devices and class I devices<\/span>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-99126c6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"99126c6\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-aa6abad\" data-id=\"aa6abad\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b83d01b elementor-widget elementor-widget-heading\" data-id=\"b83d01b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Do you feel confused about your next steps?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ae71ac3 elementor-widget elementor-widget-text-editor\" data-id=\"ae71ac3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Don\u2019t worry, we can help you through the process. Our team of specialists have extensive knowledge in all aspects of the development of medical devices. We can help you to get ready and to get your software compliant before the time runs out.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-0238886\" data-id=\"0238886\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cd00dab elementor-widget elementor-widget-image\" data-id=\"cd00dab\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2022\/04\/qms-software-rund-600-png.avif\" title=\"qms-software-rund-600\" alt=\"qms-software-rund-600\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-0670fc1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0670fc1\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5fb8083\" data-id=\"5fb8083\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fb62653 elementor-widget elementor-widget-heading\" data-id=\"fb62653\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Here is what you will get out of this tailor-made package for MDSW manufacturers:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a97704c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a97704c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-b94d5c6\" data-id=\"b94d5c6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-9f92d31 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9f92d31\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-ad54d91\" data-id=\"ad54d91\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-52311ec elementor-widget elementor-widget-image\" data-id=\"52311ec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-hat_bl-150x150.avif\" class=\"attachment-thumbnail size-thumbnail wp-image-103954\" alt=\"Student hat icon\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-hat_bl-150x150.avif 150w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-hat_bl-300x300.avif 300w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-hat_bl-100x100.avif 100w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-hat_bl.png 400w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-69afcf2 elementor-widget elementor-widget-heading\" data-id=\"69afcf2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">MDR and MDSW training<\/h3>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-957bc15 elementor-widget elementor-widget-text-editor\" data-id=\"957bc15\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li>Basic understanding of the regulatory requirements on medical device software (MDSW)<\/li><li>Qualification and classification of MDSW<\/li><li>Useful standards and guidelines<\/li><li>Software safety classification according to IEC 62304<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-0d573de\" data-id=\"0d573de\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-379efd5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"379efd5\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-bcad370\" data-id=\"bcad370\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-37e2777 elementor-widget elementor-widget-image\" data-id=\"37e2777\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-dokumentation_bl-150x150.avif\" class=\"attachment-thumbnail size-thumbnail wp-image-103956\" alt=\"Documentation icon\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-dokumentation_bl-150x150.avif 150w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-dokumentation_bl-100x100.avif 100w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-dokumentation_bl-png.avif 300w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d3f7aeb elementor-widget elementor-widget-heading\" data-id=\"d3f7aeb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">GAP Analysis&nbsp;<\/h3>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-d268b06 elementor-widget elementor-widget-text-editor\" data-id=\"d268b06\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>We perform a GAP analysis of your current QMS and technical documentation to identify possible gaps to be addressed to be MDR compliant.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-bde4b17\" data-id=\"bde4b17\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-c9676b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c9676b4\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-45716e6\" data-id=\"45716e6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b329b07 elementor-widget elementor-widget-image\" data-id=\"b329b07\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-kugghjul_bl-150x150.avif\" class=\"attachment-thumbnail size-thumbnail wp-image-103957\" alt=\"Search icon\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-kugghjul_bl-150x150.avif 150w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-kugghjul_bl-100x100.avif 100w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/09\/ikon-kugghjul_bl-png.avif 300w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-68d3293 elementor-widget elementor-widget-heading\" data-id=\"68d3293\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Workshops<\/h3>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-2be607e elementor-widget elementor-widget-text-editor\" data-id=\"2be607e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Tailored for your specific needs. For example:<\/p><ul><li>Document walk-through and update<\/li><li>Process walk-through and update<\/li><li>SW risk management<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-49b8ee1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"49b8ee1\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a7b8df4\" data-id=\"a7b8df4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-828050d elementor-widget elementor-widget-heading\" data-id=\"828050d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\"><b>Price: 99 000 SEK<\/b>\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7359649 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7359649\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d6f5976\" data-id=\"d6f5976\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-66f6ef8 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"66f6ef8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b6f04a0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b6f04a0\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-259909e\" data-id=\"259909e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-196e131 elementor-widget elementor-widget-heading\" data-id=\"196e131\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">To ensure that your Medical Device Software is MDR compliant we recommend you to:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-910dbb5 elementor-widget elementor-widget-text-editor\" data-id=\"910dbb5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li>Update or create your QMS<\/li><li>Update or create your technical documentation<\/li><li>Create a submission to a suitable notified body to CE-register your software<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-68b3f672 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"68b3f672\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7f48f1dd\" data-id=\"7f48f1dd\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-297fa664 elementor-widget elementor-widget-heading\" data-id=\"297fa664\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Webinar - Fusion of AI and Medical Devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-21b96885 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"21b96885\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a10dcd2\" data-id=\"a10dcd2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-21dec98e elementor-widget elementor-widget-heading\" data-id=\"21dec98e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Watch the recording now to stay ahead of AI compliance challenges!<\/p>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-33016dd8 elementor-widget elementor-widget-text-editor\" data-id=\"33016dd8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>Key topics include:<\/strong><\/p><ul><li>How AI-based MDSW differs from traditional software in regulatory reviews<\/li><li>The biggest challenges Notified Bodies face in assessing AI medical devices<\/li><li>Strategies to engage Notified Bodies early and avoid approval delays<\/li><li>Why AI transparency &amp; explainability are critical for regulatory success<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d1b21cc elementor-widget elementor-widget-button\" data-id=\"6d1b21cc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/lightweb.dev\/s\/key2compliance\/webinar-fusion-of-ai-and-medical-devices\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Click here for access<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-773b6838\" data-id=\"773b6838\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7461c76e elementor-widget elementor-widget-image\" data-id=\"7461c76e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/lightweb.dev\/s\/key2compliance\/webinar-fusion-of-ai-and-medical-devices\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"600\" height=\"400\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2025\/03\/BSW-Webinar-m-logga.avif\" class=\"attachment-large size-large wp-image-122144\" alt=\"Webinar: Fusion of AI and Medical Devices\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2025\/03\/BSW-Webinar-m-logga.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2025\/03\/BSW-Webinar-m-logga-300x200.avif 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-344feb21 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"344feb21\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-7a18d77a\" data-id=\"7a18d77a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3d941251 elementor-widget elementor-widget-menu-anchor\" data-id=\"3d941251\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"contact\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-19974131 elementor-widget elementor-widget-heading\" data-id=\"19974131\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Fill in this form and we will help you get ready for MDR!<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3ffecb8 elementor-button-align-end elementor-mobile-button-align-center elementor-widget elementor-widget-form\" data-id=\"3ffecb8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;Next&quot;,&quot;step_previous_label&quot;:&quot;Previous&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" name=\"Webform MDR-Software 220426\" aria-label=\"Webform MDR-Software 220426\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"74650\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"3ffecb8\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Is your Medical Device Software ready for MDR? | GBA Key2Compliance\" \/>\n\n\t\t\t\t\t\t\t<input type=\"hidden\" name=\"queried_id\" value=\"74650\"\/>\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-hidden elementor-field-group elementor-column elementor-field-group-formid elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"hidden\" name=\"form_fields[formid]\" id=\"form-field-formid\" class=\"elementor-field elementor-size-md  elementor-field-textual\" value=\"Webform MDR-Software 220426\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-firstname elementor-col-33 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-firstname\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tFirstName\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[firstname]\" id=\"form-field-firstname\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"First name\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-lastname elementor-col-33\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-lastname\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tLastName\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[lastname]\" id=\"form-field-lastname\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Last name\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-field_eb89de3 elementor-col-33\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_eb89de3\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tTitle\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[field_eb89de3]\" id=\"form-field-field_eb89de3\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Title\/position\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-company elementor-col-50\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-company\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tCompany\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[company]\" id=\"form-field-company\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Company\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tEmail\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Email\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tMessage\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-md\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"3\" placeholder=\"How can we help you?\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-html elementor-field-group elementor-column elementor-field-group-field_ec9c3a2 elementor-col-75\">\n\t\t\t\t\tWe take great care of your contact details. To learn more, read our <a href=\"\/policies-cookies\">Privacy Policy<\/a>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-recaptcha_v3 elementor-field-group elementor-column elementor-field-group-field_ca2340e elementor-col-100 recaptcha_v3-bottomright\">\n\t\t\t\t\t<div class=\"elementor-field\" id=\"form-field-field_ca2340e\"><div class=\"elementor-g-recaptcha\" data-sitekey=\"6Le7F6ggAAAAAAbZrrur_hWj9nDcJd986S-LniFR\" data-type=\"v3\" data-action=\"Form\" data-badge=\"bottomright\" data-size=\"invisible\"><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-100 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-arrow-right\"><\/i>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Send now<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/form>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-4e11bf7b\" data-id=\"4e11bf7b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Is your Medical Device Software ready for MDR? The Medical Device Regulation (MDR) is fully applicable since May 26th 2021. Although the MDR transitional provision has been extended* there is no time to lose for Medical Device Software manufacturers (MDSW) to be compliant with MDR since only then it is possible to continue updating and [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-74650","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/pages\/74650","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/comments?post=74650"}],"version-history":[{"count":3,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/pages\/74650\/revisions"}],"predecessor-version":[{"id":124107,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/pages\/74650\/revisions\/124107"}],"wp:attachment":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media?parent=74650"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}