{"id":1042,"date":"2020-03-11T06:45:41","date_gmt":"2020-03-11T06:45:41","guid":{"rendered":"https:\/\/www.iso-saudi.net\/blog\/?p=1042"},"modified":"2020-03-11T06:55:04","modified_gmt":"2020-03-11T06:55:04","slug":"leader-group-kick-starts-iso-13485-certification","status":"publish","type":"post","link":"https:\/\/www.iso-saudi.net\/blog\/leader-group-kick-starts-iso-13485-certification\/","title":{"rendered":"Leader Group kick starts ISO 13485 Certification"},"content":{"rendered":"

Leader Group kick starts ISO 13485 Certification<\/strong><\/p>\n

\"Description:<\/p>\n

Seven Steps for ISO 13485 Certification in Jeddah at LEADER HEALTHCARE<\/p>\n

    \n
  1. Conducting Risk assessment based on the ISO Standards<\/li>\n
  2. Preparation of Design control process documents<\/li>\n
  3. Validation of Design and special process<\/li>\n
  4. Writing Regulatory compliance records<\/li>\n
  5. Following Medical equipment directive as per SFDA Saudi Food and Drug Authority<\/li>\n
  6. Medical device file MDF file creation and review<\/li>\n
  7. Process Internal audit in line with ISO 13485, Review with management<\/li>\n<\/ol>\n

    ISO 13485 Quality Management System certification Riyadh<\/strong><\/p>\n

    SFDA has brought the\u00a0Medical Device<\/strong>\u00a0products for a level of understanding of the regulatory environment and implication it has on the regulatory obligations.<\/p>\n

    SFDA Saudi Food and Drug Authority KSA has constantly developing their local regulations based on the International Medical Device Regulator\u2019s Forum – IMDRF model.<\/p>\n

    Already-existing regulations tend to be assessed by SFDA and\/or accredited Certification Bodies.<\/p>\n

    The majority of these regulations have as common base the\u00a0Quality Management System (QMS)<\/strong>\u00a0and\u00a0Risk management principles of ISO 14971 Risk assessment Medical device.<\/p>\n

    What is the ISO 13485 standard?<\/strong><\/p>\n

    ISO 13485<\/strong>,\u00a0Medical devices<\/em><\/strong>\u00a0\u2013\u00a0Quality Management Systems<\/strong>\u00a0\u2013\u00a0requirements for regulatory purposes<\/strong><\/em>, is an internationally recognized standard for organizations involved in the medical device industry. \u00a0Companies are using compliance to this standard to obtain the certification of their\u00a0Quality Management System<\/strong>. The primary purpose of the\u00a0ISO 13485 standard\u00a0<\/strong>is the Harmonization of the Medical Device regulatory requirements for Quality Management Systems.<\/p>\n

    Who can be ISO 13485 certified?\u00a0<\/strong><\/p>\n

    The\u00a0ISO 13485<\/strong>\u00a0certification is a proof of\u00a0Quality Management System compliance\u00a0to the standard for organizations involved in the\u00a0Medical Device manufacturing, distribution and servicing. This approach is not only followed by\u00a0Medical Device factories and service industries\u00a0but also supporting organizations such as Subcontractors, Suppliers,\u00a0SFDA approved Representatives.<\/p>\n

    Achieving the\u00a0ISO 13485 certificate from experts<\/strong>\u00a0enhances the image of Medical device companies to which the standard can apply.<\/p>\n

    Located in Riyadh, Jeddah, Yanbu, Jubail, Dammam, Hofuf and looking for ISO 13485 Consultant, ISO 13485 Consultancy, ISO 13485 Compliance audit by expert drop an email to info@iso-saudi.net<\/p>\n","protected":false},"excerpt":{"rendered":"

    Leader Group kick starts ISO 13485 Certification Seven Steps for ISO 13485 Certification in Jeddah at LEADER HEALTHCARE Conducting Risk […]<\/p>\n","protected":false},"author":1,"featured_media":1046,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","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":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[131],"tags":[125,272,271,256,142],"class_list":["post-1042","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-iso-13485","tag-iso-13485-certification","tag-iso-13485-compliance-audit-by-expert","tag-iso-13485-consultancy","tag-iso-13485-consultant","tag-iso-13485-consultants"],"yoast_head":"\nLeader Group kick starts ISO 13485 Certification - 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