{"id":76,"date":"2024-04-15T08:32:44","date_gmt":"2024-04-15T08:32:44","guid":{"rendered":"https:\/\/kairaengineering.com\/?page_id=76"},"modified":"2024-06-19T09:06:41","modified_gmt":"2024-06-19T09:06:41","slug":"quality-assurance","status":"publish","type":"page","link":"https:\/\/kairaengineering.com\/it\/quality-assurance\/","title":{"rendered":"Quality assurance"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"76\" class=\"elementor elementor-76\" data-elementor-post-type=\"page\">\n\t\t\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-5b4ce94 e-flex e-con-boxed e-con e-parent\" data-id=\"5b4ce94\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-09694cd e-flex e-con-boxed e-con e-child\" data-id=\"09694cd\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-75fd560 elementor-widget elementor-widget-text-editor\" data-id=\"75fd560\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Our accurate and secure document management enables companies to maintain regulatory compliance and optimize internal processes.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5590c2b gradient_text elementor-widget elementor-widget-button\" data-id=\"5590c2b\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/kairaengineering.com\/it\/services\/\">\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\">SEE OUR CASE HISTORY<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-9c4aef2 e-flex e-con-boxed e-con e-parent\" data-id=\"9c4aef2\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;background_motion_fx_motion_fx_mouse&quot;:&quot;yes&quot;,&quot;background_motion_fx_mouseTrack_effect&quot;:&quot;yes&quot;,&quot;background_motion_fx_mouseTrack_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1,&quot;sizes&quot;:[]}}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-8030084 e-flex e-con-boxed e-con e-child\" data-id=\"8030084\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-90cd3b1 gradient_text elementor-widget elementor-widget-heading\" data-id=\"90cd3b1\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Quality management<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e5d7b9e elementor-widget elementor-widget-heading\" data-id=\"e5d7b9e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Guidelines we abide to.<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-69598e3 elementor-widget elementor-widget-text-editor\" data-id=\"69598e3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Our expertise in ensuring <strong>strict compliance with international regulations<\/strong>, supported by a systematic approach. Aligned with the highest global standards, such as:<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-12fc573 e-grid e-con-boxed e-con e-child\" data-id=\"12fc573\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-f780c16 e-con-full e-flex e-con e-child\" data-id=\"f780c16\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-01e27d7 number_gradient elementor-widget elementor-widget-text-editor\" data-id=\"01e27d7\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>IEC 62304<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a53de6a elementor-widget elementor-widget-heading\" data-id=\"a53de6a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Software life cycle<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1c2e00 elementor-widget elementor-widget-text-editor\" data-id=\"a1c2e00\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Medical Device Software\u00a0Software Life Cycle Processes<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-0e90513 e-con-full e-flex e-con e-child\" data-id=\"0e90513\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c202d21 number_gradient elementor-widget elementor-widget-text-editor\" data-id=\"c202d21\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>ISO 14971<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18971da elementor-widget elementor-widget-heading\" data-id=\"18971da\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Risk management:<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26ccfbf elementor-widget elementor-widget-text-editor\" data-id=\"26ccfbf\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Medical Devices\u00a0Application of Risk Management\u00a0to Medical Devices<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-c8b7c16 e-con-full e-flex e-con e-child\" data-id=\"c8b7c16\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b871c21 number_gradient elementor-widget elementor-widget-text-editor\" data-id=\"b871c21\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>IEC 62366<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0e4cbcf elementor-widget elementor-widget-heading\" data-id=\"0e4cbcf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Usability engineering:<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c1e388e elementor-widget elementor-widget-text-editor\" data-id=\"c1e388e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Medical Device Software Usability Engineering Processes<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-5422a6d e-flex e-con-boxed e-con e-child\" data-id=\"5422a6d\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8202825 gradient_text elementor-widget elementor-widget-heading\" data-id=\"8202825\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">CERTIFICATIONS<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3ddc47d elementor-widget elementor-widget-heading\" data-id=\"3ddc47d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The importance of the correct certifications.<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8f5fa86 elementor-widget elementor-widget-text-editor\" data-id=\"8f5fa86\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Too many medical device manufacturers <strong>expose themselves to weaknesses and vulnerabilities by not aligning their processes with ISO and IEC standards<\/strong>. This results in a backlog for development and, more importantly, a longer time-to-market.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-7b9ccf0 e-grid e-con-boxed e-con e-child\" data-id=\"7b9ccf0\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-5fdf719 e-con-full e-flex e-con e-child\" data-id=\"5fdf719\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2be076e number_gradient elementor-widget elementor-widget-text-editor\" data-id=\"2be076e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b> 9001: 2015<\/b><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c5dfe9 elementor-widget elementor-widget-heading\" data-id=\"3c5dfe9\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">UNI ISO 9001: 2015<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-762c28c gradient_text elementor-widget elementor-widget-heading\" data-id=\"762c28c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Under accreditation by end 2024<\/h5>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-element elementor-element-e3c9035 e-con-full e-flex e-con e-child\" data-id=\"e3c9035\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-efed0cf number_gradient elementor-widget elementor-widget-text-editor\" data-id=\"efed0cf\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>13485: 2016<\/b><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-120f163 elementor-widget elementor-widget-heading\" data-id=\"120f163\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">UNI ISO 13485: 2016<\/h4>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-305f7b9 gradient_text elementor-widget elementor-widget-heading\" data-id=\"305f7b9\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Under accreditation by end 2024<\/h5>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Our accurate and secure document management enables companies to maintain regulatory compliance and optimize internal processes. SEE OUR CASE HISTORY Quality management Guidelines we abide to. Our expertise in ensuring strict compliance with international regulations, supported by a systematic approach. 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