Medical Devices Management Systems
\nISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. <\/p>\n
Organizations involved in medical device industry see ISO 13485 as the de facto standard towards regulatory compliance.<\/p>\n
Benefits of implementing ISO 13485 Management System
\n\u2022Global Recognition
\n\u2022Improved legal and regulatory or contractual requirements compliance
\n\u2022Assistance in monitoring supply chain effectiveness
\n\u2022Increased profit margins
\n\u2022Improved product safety
\n\u2022Increased Efficiency
\n\u2022Proactive error detection and prevention
\n\u2022Cost Savings
\n\u2022More Effective Risk Management
\n\u2022Increased likelihood of meeting Customer Requirements<\/p>\n
Benefits of ISO 13485 Certification to the clients:
\n\u2022Quality ensured medical devices
\n\u2022Safe and effective medical devices
\n\u2022Lower skepticism and increased confidence for end-customer<\/p>\n
ISO 13485:2016 certification is a third-party audit performed by PQS, upon verification that an organization is in compliance with the requirements of standard, will issue compliance certificate. Certification is then maintained through regularly scheduled annual surveillance audits, with re-certification performed on a triennial basis.<\/p>\n","protected":false},"excerpt":{"rendered":"
Medical Devices Management Systems ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Organizations involved in medical device industry see ISO 13485 as the de […]<\/p>\n","protected":false},"author":1,"featured_media":380,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[3],"tags":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=\/wp\/v2\/posts\/379"}],"collection":[{"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=379"}],"version-history":[{"count":2,"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=\/wp\/v2\/posts\/379\/revisions"}],"predecessor-version":[{"id":385,"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=\/wp\/v2\/posts\/379\/revisions\/385"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=\/wp\/v2\/media\/380"}],"wp:attachment":[{"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=379"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=379"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pqscert-sa.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=379"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}