{"id":24739,"date":"2021-01-20T08:22:17","date_gmt":"2021-01-20T08:22:17","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/?post_type=product&#038;p=24739"},"modified":"2026-04-14T15:47:37","modified_gmt":"2026-04-14T13:47:37","slug":"ivdr-and-requirements-on-the-quality-management-system","status":"publish","type":"product","link":"https:\/\/lightweb.dev\/s\/key2compliance\/product\/ivdr-and-requirements-on-the-quality-management-system\/","title":{"rendered":"IVDR and requirements on the Quality Management System &#8211; Course"},"content":{"rendered":"<p>&#8211; What are the requirements on legal manufacturers to achieve CE-certification for in-vitro diagnostic devices?<br \/>\n&#8211; What will the NB need look for when auditing our Quality Management System?<br \/>\n&#8211; What is the responsibility of the PRRC, in relation to the QMS?<\/p>\n<p>This training will give you the answers!<\/p>\n<h3>Course description<\/h3>\n<p>After this 1 day training, you will be better equipped to tackle the questions above.<br \/>\nWe\u2019ll walk you through the key IVDR requirements on your Quality Management System and provide you with tools to perform a gap analysis and perform an update of your quality management system, to ensure compliance with the IVDR. The relationship between ISO13485:2016 and IVDR, and the role &amp; responsibilities of the PRRC will be clarified.<\/p>\n<p>To get the full understanding of IVDR requirements on Quality Management System, Risk Management and the Technical File.<\/p>\n<h3>Course outline<\/h3>\n<ul>\n<li>Understand the impact of IVDR to your quality management system<\/li>\n<li>Responsibilities of the PRRC \u2013 Person Responsible for Regulatory Compliance<\/li>\n<li>How to utilize ISO13485:2016 to ensure compliance to the regulation.<\/li>\n<li>Assess and audit your internal quality management system against IVDR<\/li>\n<\/ul>\n<h3>Learning objectives<\/h3>\n<p>Completion of this course will give you the knowledge needed to assess and update your current quality management system for IVDR compliance, make use of ISO13485:2016 to manage key regulatory requirements and apply a risk-based approach.<\/p>\n<h3>Who should attend<\/h3>\n<p>Quality Managers, the PRRC (Person Responsible for Regulatory Compliance), the Management Representative, of an IVD Manufacturer. \u00a0Quality Specialists\/ Engineers, RA Managers\/Specialists, Persons involved in Design &amp; Development, \u00a0writing or maintaining Technical Documentation, such as: Design and development engineers, \u00a0Quality representatives in design and development projects, or the Head of R&amp;D.<\/p>\n<h3>Prerequisites<\/h3>\n<ul>\n<li>You should have knowledge of medical device quality systems from working with IVDD and\/or ISO13485..<\/li>\n<li>You should have at least 2 years of experience from the medical device industry.<\/li>\n<\/ul>\n<p>#5138<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&#8211; What are the requirements on legal manufacturers, to achieve CE-certification for in-vitro diagnostic devices?<br \/>\n&#8211; What will the NB need look for when auditing our Quality Management System?<br \/>\n&#8211; What is the responsibility of the PRRC, in relation to the QMS?<br \/>\nThis training will give you the answers!<\/p>\n","protected":false},"featured_media":24740,"template":"","meta":{"_acf_changed":false,"wds_primary_product_brand":0,"wds_primary_product_cat":0},"product_brand":[],"product_cat":[18],"product_tag":[106,95],"class_list":{"0":"post-24739","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-in-house","7":"product_tag-in-vitro-diagnostics","8":"product_tag-quality-management-and-qa","9":"pa_industry-ivd","10":"pa_industry-medical-device","11":"pa_language-english","12":"pa_level-intermediate","13":"pa_location-online","14":"pa_region-eu","16":"first","17":"instock","18":"virtual","19":"taxable","20":"purchasable","21":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product\/24739","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media\/24740"}],"wp:attachment":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media?parent=24739"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_brand?post=24739"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_cat?post=24739"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_tag?post=24739"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}