{"product_id":"iso-13485-foundation","title":"ISO 13485 Foundation","description":"\u003cdiv class=\"elementor-element elementor-element-27f839d elementor-widget elementor-widget-text-editor\" data-id=\"27f839d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\"\u003e\n\u003ch2\u003eWhy should you attend?\u003c\/h2\u003e\n\u003cdiv\u003e\n\u003ca href=\"https:\/\/pecb.com\/en\/education-and-certification-for-individuals\/iso-13485\"\u003eISO 13485\u003c\/a\u003e Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.\u003c\/div\u003e\n\u003cdiv\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv\u003eAfter completing this course, you can sit for the exam and apply for the “PECB Certificate Holder in ISO 13485 Foundation” certificate. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"elementor-element elementor-element-de93b7e elementor-widget elementor-widget-text-editor\" data-id=\"de93b7e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\"\u003e\n\u003ch2\u003eWho should attend?\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eIndividuals involved in Medical Devices Quality Management\u003c\/li\u003e\n\u003cli\u003eIndividuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)\u003c\/li\u003e\n\u003cli\u003eIndividuals interested to pursue a career in Medical Devices Quality Management\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eLearning objectives\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eUnderstand the elements and operations of a Medical Devices Quality Management System (MDQMS)\u003c\/li\u003e\n\u003cli\u003eAcknowledge the correlation between ISO 13485 and other standards and regulatory frameworks\u003c\/li\u003e\n\u003cli\u003eUnderstand the approaches, methods and techniques used for the implementation and  management of a MDQMS\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eEducational approach\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eLecture sessions are illustrated with practical questions and examples\u003c\/li\u003e\n\u003cli\u003ePractical exercises include examples and discussions\u003c\/li\u003e\n\u003cli\u003ePractice tests are similar to the Certificate Exam\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003ePrerequisites\u003c\/h2\u003e\n\u003cp\u003eNone.\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003e\u003cspan lang=\"EN-US\" style=\"font-size: 14.0pt; line-height: 115%; font-family: 'Aptos Display',sans-serif; mso-ascii-theme-font: major-latin; mso-fareast-font-family: 'Times New Roman'; mso-hansi-theme-font: major-latin; mso-bidi-font-family: 'Times New Roman'; mso-font-kerning: 18.0pt; mso-ligatures: none; mso-ansi-language: EN-US; mso-fareast-language: EN-CA;\"\u003eCourse Agenda\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 1\u003c\/strong\u003e: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 2\u003c\/strong\u003e: Medical Devices Quality Management System requirements and Certificate Exam\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003e\u003cspan lang=\"EN-US\" style=\"font-size: 14.0pt; line-height: 115%; font-family: 'Aptos Display',sans-serif; mso-ascii-theme-font: major-latin; mso-fareast-font-family: 'Times New Roman'; mso-hansi-theme-font: major-latin; mso-bidi-font-family: 'Times New Roman'; mso-font-kerning: 18.0pt; mso-ligatures: none; mso-ansi-language: EN-US; mso-fareast-language: EN-CA;\"\u003eExamination\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003eThe exam fully meets the requirements of the PECB Examination and Certificate Programme. It covers the following competency domains:\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 1:\u003c\/strong\u003e Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 2:\u003c\/strong\u003e Medical Devices Quality Management System (MDQMS)\u003c\/p\u003e\n\u003cp\u003eFor specific information about exam type, languages available, and other details, please visit the \u003ca href=\"https:\/\/help.pecb.com\/index.php\/list-of-pecb-exams\/\"\u003eList of PECB Exams\u003c\/a\u003e and the \u003ca href=\"https:\/\/pecb.com\/examination-rules-and-policies\"\u003eExamination Rules and Policies\u003c\/a\u003e.\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003e\u003cspan lang=\"EN-US\" style=\"font-size: 14.0pt; line-height: 115%; font-family: 'Aptos Display',sans-serif; mso-ascii-theme-font: major-latin; mso-fareast-font-family: 'Times New Roman'; mso-hansi-theme-font: major-latin; mso-bidi-font-family: 'Times New Roman'; mso-font-kerning: 18.0pt; mso-ligatures: none; mso-ansi-language: EN-US; mso-fareast-language: EN-CA;\"\u003eCertificate requirements\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cdiv class=\"elementor-element elementor-element-79358cf e-con-full pecb_training_container e-flex e-con e-child\" data-id=\"79358cf\" data-element_type=\"container\" data-e-type=\"container\"\u003e\n\u003cdiv class=\"elementor-element elementor-element-dcbfe78 e-con-full pecb_training_body e-flex e-con e-child\" data-id=\"dcbfe78\" data-element_type=\"container\" data-e-type=\"container\"\u003e\n\u003cdiv class=\"elementor-element elementor-element-1755052 e-con-full e-flex e-con e-child\" data-id=\"1755052\" data-element_type=\"container\" data-e-type=\"container\"\u003e\n\u003cdiv class=\"elementor-element elementor-element-8e58bf5 other_details e-n-tabs-mobile elementor-widget elementor-widget-n-tabs\" data-id=\"8e58bf5\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings='{\"tabs_justify_horizontal\":\"start\",\"horizontal_scroll\":\"disable\"}' data-widget_type=\"nested-tabs.default\"\u003e\n\u003cdiv class=\"e-n-tabs e-activated\" data-widget-number=\"149261301\" aria-label=\"Tabs. Open items with Enter or Space, close with Escape and navigate using the Arrow keys.\" data-touch-mode=\"false\"\u003e\n\u003cdiv class=\"e-n-tabs-content\"\u003e\n\u003cdiv id=\"e-n-tab-content-1492613013\" role=\"tabpanel\" aria-labelledby=\"e-n-tab-title-1492613013\" data-tab-index=\"3\" class=\"elementor-element elementor-element-c6c442e e-con-full e-flex e-con e-child e-active\" data-id=\"c6c442e\" data-element_type=\"container\" data-e-type=\"container\"\u003e\n\u003cdiv class=\"elementor-element elementor-element-90dc316 elementor-widget elementor-widget-text-editor\" data-id=\"90dc316\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\"\u003e\n\u003cp\u003eAfter successfully completing the exam, you can apply for the credential shown on the table below.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe certificate requirements for the ISO 13485 Foundation are:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv\u003e\n\u003ctable\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eDesignation\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eTraining Course\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eExam\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eProfessional experience\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eMS audit\/assessment experience\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eBCMS project experience\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eOther requirements\u003c\/strong\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003e\u003cstrong\u003ePECB Certificate Holder in ISO 13485 Foundation\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003ePECB ISO 13485 Foundation\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003ePass the PECB ISO 13485 Foundation Exam\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eNone\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eNone\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eNone\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eSigning the PECB Code of Ethics\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"elementor-element elementor-element-4ddb810 elementor-widget elementor-widget-html\" data-id=\"4ddb810\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003e\u003cspan lang=\"EN-US\" style=\"font-size: 14.0pt; line-height: 115%; font-family: 'Aptos Display',sans-serif; mso-ascii-theme-font: major-latin; mso-fareast-font-family: 'Times New Roman'; mso-hansi-theme-font: major-latin; mso-bidi-font-family: 'Times New Roman'; mso-font-kerning: 18.0pt; mso-ligatures: none; mso-ansi-language: EN-US; mso-fareast-language: EN-CA;\"\u003eGeneral Information\u003c\/span\u003e\u003c\/b\u003e\u003cb\u003e\u003cspan lang=\"EN-US\" style=\"font-size: 14.0pt; line-height: 115%; font-family: 'Aptos Display',sans-serif; mso-ascii-theme-font: major-latin; mso-hansi-theme-font: major-latin; mso-ansi-language: EN-US;\"\u003e\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eCertificate and examination fees are included in the price of the training course\u003c\/li\u003e\n\u003cli\u003eTraining material containing over 200 pages of information and practical examples will be distributed\u003c\/li\u003e\n\u003cli\u003eAn attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.\u003c\/li\u003e\n\u003cli\u003eIn case of exam failure, you can retake the exam within 12 months for free\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eFor additional information, please contact us at \u003ca href=\"mailto:support@pecb.com\"\u003esupport@pecb.com\u003c\/a\u003e.\u003c\/p\u003e\n\u003c\/div\u003e","brand":"PECB","offers":[{"title":"Default Title","offer_id":46104628789305,"sku":null,"price":499.0,"currency_code":"CAD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0711\/4453\/8169\/files\/pecb-slogan-bottom-150x150.png?v=1740368139","url":"https:\/\/shop.martialtech.ca\/products\/iso-13485-foundation","provider":"Martial Technology","version":"1.0","type":"link"}