{"product_id":"iso-13485-lead-implementer","title":"ISO 13485 Lead Implementer","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\u003cp\u003eISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.\u003c\/p\u003e\n\u003cp\u003eAfter mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.\u003c\/p\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\u003eManagers or consultants involved in Medical Devices Quality Management\u003c\/li\u003e\n\u003cli\u003eExpert advisors seeking to master the implementation of a Medical Devices Quality Management System\u003c\/li\u003e\n\u003cli\u003eIndividuals responsible for maintaining conformance with MDQMS requirements\u003c\/li\u003e\n\u003cli\u003eMDQMS team members\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eLearning objectives\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eAcknowledge the correlation between ISO 13485 and other standards and regulatory frameworks\u003c\/li\u003e\n\u003cli\u003eMaster the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS\u003c\/li\u003e\n\u003cli\u003eLearn how to interpret the ISO 13485 requirements in the specific context of an organization\u003c\/li\u003e\n\u003cli\u003eLearn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS\u003c\/li\u003e\n\u003cli\u003eAcquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eEducational approach\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eThis training is based on both theory and best practices used in the implementation of a MDQMS\u003c\/li\u003e\n\u003cli\u003eLecture sessions are illustrated with examples based on case studies\u003c\/li\u003e\n\u003cli\u003ePractical exercises are based on a case study which includes role playing and discussions\u003c\/li\u003e\n\u003cli\u003ePractice tests are similar to the Certification Exam\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003ePrerequisites\u003c\/h2\u003e\n\u003cdiv\u003e\n\u003cdiv id=\"4450\"\u003e\n\u003cdiv\u003e\n\u003cdiv id=\"76\"\u003e\n\u003cp\u003eA fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.\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 ISO 13485 and initiation of a MDQMS\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 2:\u003c\/strong\u003e Plan the implementation of a MDQMS\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 3:\u003c\/strong\u003e Implementation of a MDQMS\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 4:\u003c\/strong\u003e MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 5: \u003c\/strong\u003eCertification 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 “PECB Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 1: \u003c\/strong\u003eFundamental 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\u003e\u003cstrong\u003eDomain 3:\u003c\/strong\u003e Planning a MDQMS implementation based on ISO 13485\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 4:\u003c\/strong\u003e Implementing a MDQMS based on ISO 13485\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 5:\u003c\/strong\u003e Performance evaluation, monitoring and measurement of a MDQMS based on ISO 13485\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 6:\u003c\/strong\u003e Continual improvement of a MDQMS based on ISO 13485\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 7: \u003c\/strong\u003ePreparing for a MDQMS certification audit\u003c\/p\u003e\n\u003cp\u003eFor specific information about exam types, languages available, and other details, please visit the \u003ca href=\"https:\/\/pecb.com\/help\/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 credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential. For more information about ISO 13485 certifications and the PECB certification process, please refer to the \u003ca href=\"https:\/\/pecb.com\/en\/certification-rules-and-policies\"\u003eCertification Rules and Policies\u003c\/a\u003e.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe requirements for PECB Implementer Certifications are:\u003c\/strong\u003e\u003c\/p\u003e\n\u003ctable\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eCredential\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\u003eMDQMMS 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 Certified ISO 13485 Provisional Implementer\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003ePECB Certified ISO 13483 Lead Implementer Exam or equivalent\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\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003e\u003cstrong\u003ePECB Certified ISO 13485 Implementer\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003ePECB Certified ISO 13483 Lead Implementer Exam or equivalent\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eTwo Years: One year of work experience in Medical Devices Quality Management\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eProject activities: a total of 200 hours\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eSigning of the PECB Code of Ethics\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003e\u003cstrong\u003ePECB Certified ISO 13485 Lead Implementer\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003ePECB Certified ISO 13483 Lead Implementer Exam or equivalent\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eFive Years: Two years of work experience in Medical Devices Quality Management\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eProject activities: a total of 300 hours\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eSigning of the PECB Code of Ethics\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003e\u003cstrong\u003ePECB Certified ISO 13485 Senior Lead Implementer\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003ePECB Certified ISO 13483 Lead Implementer Exam or equivalent\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eTen Years: Seven years of work experience in Medical Devices Quality Management\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eProject activities: a total of 1,000 hours\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eSigning of the PECB Code of Ethics\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003cp\u003e\u003cstrong\u003eTo be considered valid, these implementation activities should follow best implementation practices and include the following activities:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv\u003e\n\u003col\u003e\n\u003cli\u003eDrafting a MDQMS plan\u003c\/li\u003e\n\u003cli\u003eInitiating a MDQMS implementation\u003c\/li\u003e\n\u003cli\u003eImplementing a MDQMS\u003c\/li\u003e\n\u003cli\u003eMonitoring and managing a MDQMS implementation\u003c\/li\u003e\n\u003cli\u003ePerforming continual improvement measures\u003c\/li\u003e\n\u003c\/ol\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\u003eCertification and examination fees are included in the price of the training course\u003c\/li\u003e\n\u003cli\u003eTraining material containing over 450 pages of information and practical examples will be distributed\u003c\/li\u003e\n\u003cli\u003eAn attestation of course completion worth 31 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 \u003ca href=\"mailto:support@pecb.com\"\u003esupport@pecb.com\u003c\/a\u003e.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"PECB","offers":[{"title":"Default Title","offer_id":46104781520953,"sku":null,"price":999.0,"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-lead-implementer","provider":"Martial Technology","version":"1.0","type":"link"}