{"id":1058,"date":"2024-01-11T13:44:39","date_gmt":"2024-01-11T05:44:39","guid":{"rendered":"https:\/\/www.kanglifehealth.com\/?page_id=1058"},"modified":"2024-04-04T12:20:50","modified_gmt":"2024-04-04T04:20:50","slug":"%e8%b4%a8%e9%87%8f%e7%ae%a1%e7%90%86%e4%bd%93%e7%b3%bb%e8%be%85%e5%af%bc","status":"publish","type":"page","link":"https:\/\/www.kanglifehealth.com\/en\/%e8%b4%a8%e9%87%8f%e7%ae%a1%e7%90%86%e4%bd%93%e7%b3%bb%e8%be%85%e5%af%bc\/","title":{"rendered":"Quality Management System Consulting"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"1058\" class=\"elementor elementor-1058\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e215bc7 e-flex e-con-boxed e-con e-parent\" data-id=\"e215bc7\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-106329d e-con-full e-flex e-con e-child\" data-id=\"106329d\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;full&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8987177 elementor-widget elementor-widget-heading\" data-id=\"8987177\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.19.0 - 29-01-2024 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">Quality Management System Consulting<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4f40bbb elementor-widget elementor-widget-text-editor\" data-id=\"4f40bbb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.19.0 - 29-01-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Medical device quality management system is an important method to ensure the quality of medical devices, and its importance is self-evident. Mainstream medical device markets countries have similar requirements for quality management systems. However, it is a big problem for many companies to quickly identify the different requirements of different quality management systems and implement them into the quality management system.<\/p><p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0Kanglife has the team of experts who have been engaged in quality management system management and certification for many years, and can guide companies to quickly establish quality management systems with different requirements.<\/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\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-fhsa7cs elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fhsa7cs\" data-element_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-0774ce9\" data-id=\"0774ce9\" data-element_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-7586c77 elementor-widget elementor-widget-heading\" data-id=\"7586c77\" 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\">ISO 13485<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-54c3204 elementor-widget elementor-widget-text-editor\" data-id=\"54c3204\" 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 13485 Medical Devices Quality management systems Requirements for regulatory purposes was released by the International Organization for Standardization ISO\/TC 210. The currently valid version is the 2016 version.<\/p><p>\u00a0ISO 13485:2016 sets out the requirements for a quality management system that an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. These organizations may be involved in one or more stages of the life cycle, including the design and development, production, storage and distribution, installation or repair of medical devices, as well as the design and development or provision of related activities (such as technical support). ISO 13485:2016 may also be used by suppliers or external parties who provide products (including quality management system related services) to such organizations.<\/p><p>ISO 13485:2016 is currently the most widely recognized quality management system.<\/p>\t\t\t\t\t\t<\/div>\n\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-538feee\" data-id=\"538feee\" data-element_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-dfb37fb elementor-widget elementor-widget-image\" data-id=\"dfb37fb\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.19.0 - 29-01-2024 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"768\" height=\"830\" src=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/what-is-iso-13485-768x830-1.png\" class=\"attachment-full size-full wp-image-1471\" alt=\"\" srcset=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/what-is-iso-13485-768x830-1.png 768w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/what-is-iso-13485-768x830-1-278x300.png 278w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\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-e642242 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e642242\" data-element_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-5a14d99\" data-id=\"5a14d99\" data-element_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-d30a2c3 elementor-widget elementor-widget-image\" data-id=\"d30a2c3\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"150\" height=\"150\" src=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/02\/FDA-150x150.png\" class=\"attachment-thumbnail size-thumbnail wp-image-1613\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\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-0484998\" data-id=\"0484998\" data-element_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-06f761c elementor-widget elementor-widget-heading\" data-id=\"06f761c\" 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\">QMSR (Formerly QSR 820)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-90b0ed2 elementor-widget elementor-widget-text-editor\" data-id=\"90b0ed2\" 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>The U.S. Food and Drug Administration (FDA) has formulated regulations regulating the quality system requirements of medical device companies based on the Federal Food, Drug, and Cosmetic Act, the highest legal document on medical device management. That is Quality System Regulation, referred to as QMSR.<\/p>\n<p>QMSR describes the requirements for Current Good Manufacturing Practice (CGMP). It specifies the methods, facilities, and controls used in the design, manufacture, packaging, labelling, storage, installation, and service of all medical devices. These requirements are designed to ensure that the finished medical device is safe and effective and complies with the U.S. Food, Drug, and Cosmetic Act.<\/p>\n<p>QMSR sets out basic requirements applicable to medical device manufacturers. All companies selling medical devices to the United States are responsible for understanding, implementing and complying with the requirements of this part of the regulations. They are the basic requirements that most medical devices must comply with before being put on the market in the United States and may be randomly inspected at any time after being put on the market. This kind of spot inspection is commonly known as FDA factory inspection or unannounced inspection.<\/p>\t\t\t\t\t\t<\/div>\n\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-fb44667 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fb44667\" data-element_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-c8f7984\" data-id=\"c8f7984\" data-element_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-ed3c03b elementor-widget elementor-widget-heading\" data-id=\"ed3c03b\" 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\">GMP<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-44b8fec elementor-widget elementor-widget-text-editor\" data-id=\"44b8fec\" 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>China GMP, the Good Manufacturing Practice for Medical Devices, is to strengthen the supervision and management of medical device production and standardize the production quality management of medical devices. According to the \"Regulations on the Supervision and Administration of Medical Devices\" , \"Measures for the Supervision and Administration of Medical Device Production\" . China's GMP is a regulatory requirement and requires mandatory implementation. That is to say, medical devices produced and sold in China must comply with GMP requirements.<\/p>\t\t\t\t\t\t<\/div>\n\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-c1ad8ed\" data-id=\"c1ad8ed\" data-element_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-782379f elementor-widget elementor-widget-image\" data-id=\"782379f\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/gmp.png\" class=\"attachment-full size-full wp-image-1480\" alt=\"\" srcset=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/gmp.png 800w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/gmp-300x300.png 300w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/gmp-150x150.png 150w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/gmp-768x768.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\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-3943bf5 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3943bf5\" data-element_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-301d0e5\" data-id=\"301d0e5\" data-element_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-fa2cb5e elementor-widget elementor-widget-image\" data-id=\"fa2cb5e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"248\" height=\"175\" src=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/\u4e0b\u8f7d-e1707052618743.png\" class=\"attachment-full size-full wp-image-1473\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\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-809b7c9\" data-id=\"809b7c9\" data-element_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-999ffbc elementor-widget elementor-widget-heading\" data-id=\"999ffbc\" 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\">MDSAP<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5de4e48 elementor-widget elementor-widget-text-editor\" data-id=\"5de4e48\" 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>The Medical Device Single Audit Program (MDSAP) was initiated by the International Medical Device Regulators Forum (IMDRF) and is based on ISO 13485, combining five participating countries (the United States, Canada, Brazil, Australia and Japan). ) regulatory requirements, a program that meets the regulatory requirements of multiple countries will be audited by an accredited audit agency. The Medical Device Single Audit Program (MDSAP) provides a single quality management system (QMS) audit that meets the requirements of all participating regulatory agencies.<\/p><p><strong>MDSAP Advantages<\/strong><\/p><p>To put it simply: Get the certificate once and travel to five countries (Austria, Brazil, Canada, Japan, and the United States)<\/p><ul><li>Reduce the burden and disruption of multiple regulatory audits for medical device manufacturers<\/li><li>Provide a predictable audit plan (including audit start and end schedules)<\/li><li>Access multiple markets with a single audit to improve patient health and access to treatments, benefiting a broad range of patients<\/li><li>Leverage regulatory resources to save time and costs<\/li><li>ISO 13485 (Medical Device QMS) review can be included<\/li><li>Audit requirements include regulatory requirements in Australia, Brazil, Canada, Japan and the United States<\/li><li>Reduce time and resources spent processing multiple audit findings<\/li><li>Improve industry transparency<\/li><li>Currently, it is more expensive for medical devices to enter the EU regulatory market than in the past. MDSAP provides new possibilities for overseas markets and keeps the cost at an acceptable level.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\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-daa2035 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"daa2035\" data-element_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-e767510\" data-id=\"e767510\" data-element_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-f69a079 elementor-widget elementor-widget-heading\" data-id=\"f69a079\" 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\">IVDR\/MDR Quality Management System Upgrade<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc23835 elementor-widget elementor-widget-text-editor\" data-id=\"bc23835\" 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 class=\" translation-block\">Regarding the quality management system, Article 10, Point 8, of the EU MDR\/IVDR Regulation clearly requires: Manufacturers shall ensure that the necessary processes are adopted to make the production of product series comply with the requirements of this regulation.<\/p><p class=\" translation-block\">A quality management system that meets the requirements of MDR\\IVDR regulations should at least include the following aspects:<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">1<\/span>\u3001Regulatory compliance strategy, including compliance with compliance assessment processes and change management of devices covered by the system<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">2<\/span>\u3001Identify applicable general safety and performance requirements, and identify options to meet these requirements<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">3<\/span>\u3001Management responsibilities<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">4<\/span>\u3001Resource management, including selecting and managing suppliers and subcontractors<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">5<\/span>\u3001Risk Management<\/p><p class=\"MsoNormal translation-block\" style=\"text-indent: 21pt;\" align=\"left\">6\u3001Clinical evaluation\/performance evaluation, including post-marketing PMCF\/PMPF<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">7<\/span>\u3001Product realization, including planning, design, research and development, production and service provision<\/p><p class=\"MsoNormal translation-block\" style=\"text-indent: 21pt;\" align=\"left\">8\u3001Verify UDI assignments for all relevant devices and ensure consistency and validity of the information provided<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">9<\/span>\u3001Post-marketing supervision system, establishing, implementing and maintaining the post-marketing supervision system<\/p><p class=\"MsoNormal translation-block\" style=\"text-indent: 21pt;\" align=\"left\">10\u3001Communicate with competent authorities, notified bodies, other economic operators, customers and\/or other stakeholders<\/p><p class=\"MsoNormal translation-block\" style=\"text-indent: 21pt;\" align=\"left\">11\u3001Incident Reporting &amp; FSCA: Reporting process for serious incidents and on-site safety corrective measures under alert conditions<\/p><p class=\"MsoNormal translation-block\" style=\"text-indent: 21pt;\" align=\"left\">12\u3001CAPA Management: Management of corrective and preventive actions and verification of their effectiveness<\/p><p class=\"MsoNormal\" style=\"text-indent: 21pt;\" align=\"left\"><span lang=\"EN-US\">13<\/span>\u3001Monitor and Measure: Monitor and evaluation processes for products, data analysis, and product improvements<\/p>\t\t\t\t\t\t<\/div>\n\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-76f1287\" data-id=\"76f1287\" data-element_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-fbcfea6 elementor-widget elementor-widget-image\" data-id=\"fbcfea6\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"868\" height=\"540\" src=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/EU-MDR-IVDR.png\" class=\"attachment-full size-full wp-image-1468\" alt=\"\" srcset=\"https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/EU-MDR-IVDR.png 868w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/EU-MDR-IVDR-300x187.png 300w, https:\/\/www.kanglifehealth.com\/wp-content\/uploads\/2024\/01\/EU-MDR-IVDR-768x478.png 768w\" sizes=\"(max-width: 868px) 100vw, 868px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\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>","protected":false},"excerpt":{"rendered":"<p>\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8f85\u5bfc \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u662f\u4fdd\u8bc1\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7684\u91cd\u8981\u624b\u6bb5\uff0c\u5176\u91cd\u8981\u6027\u4e0d\u8a00\u800c\u55bb\u3002\u800c\u533b [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"enabled","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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