Download Technical Information<\/a><\/b><\/p>\n","protected":false},"excerpt":{"rendered":"The objective of the course is to provide students with the understanding of the ISO 13485:2016 and the quality management systems requirements which are essential to organizations involved in the design, production, installation and servicing of medical devices and related services.<\/p>\n
Through hands-on activities and case studies, students will gain valuable experience in navigating compliance challenges and addressing quality management issues.<\/p>\n
At The End Of The Course You Will Be Able To<\/h4>\n\n- Understand the general connection and differences between the ISO 13485 and the 21 CFR Part 820.<\/li>\n<\/ul>\n
\n- Know key factors to comply and maintain compliance to the ISO 13485.<\/li>\n<\/ul>\n
\n- Understand how a company\u2019s quality management system fulfils and is connected to the ISO 13485.<\/li>\n<\/ul>\n
\n- Learn to interpret ISO 13485 general requirements in the specific context of the medical device industry.<\/li>\n<\/ul>\n
\n- Learn the general requirements from each clause of the ISO13485 and how they correlate to the company quality system and procedures.<\/li>\n<\/ul>\n
\n- Experience and apply ISO 13485 requirements to solve real case situations during the class that a professional in this industry could face to maintain compliance.<\/li>\n<\/ul>\n
Course content<\/h4>\n\n- Overview<\/li>\n
- Quality management system<\/li>\n
- Management responsibility<\/li>\n
- Resource management<\/li>\n
- \u00a0Product realization\n
\n- Planning of product realization<\/li>\n
- Customer-related processes<\/li>\n
- Design and development<\/li>\n
- Purchasing<\/li>\n
- Production and service provision<\/li>\n
- Control of monitoring and measuring equipment<\/li>\n<\/ul>\n<\/li>\n
- Measurement, analysis, and improvement\n
\n- Monitoring and measurement<\/li>\n
- Control of nonconforming product<\/li>\n
- Analysis of dataImprovement<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n","protected":false},"featured_media":769,"comment_status":"open","ping_status":"closed","template":"","meta":{"_acf_changed":false},"product_cat":[25],"product_tag":[],"class_list":{"0":"post-1101","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-fundamentalsforthemedicaldevicesindustry","8":"first","9":"instock","10":"downloadable","11":"virtual","12":"taxable","13":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1101","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/comments?post=1101"}],"version-history":[{"count":9,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1101\/revisions"}],"predecessor-version":[{"id":2518,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product\/1101\/revisions\/2518"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media\/769"}],"wp:attachment":[{"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/media?parent=1101"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_cat?post=1101"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/smdlearning.com\/wp-json\/wp\/v2\/product_tag?post=1101"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}