{"id":375587,"date":"2025-01-20T10:53:48","date_gmt":"2025-01-20T15:53:48","guid":{"rendered":"https:\/\/caiready.com\/life-sciences\/?post_type=case-study&p=375587"},"modified":"2025-06-22T15:49:36","modified_gmt":"2025-06-22T19:49:36","slug":"mdr-compliance-project","status":"publish","type":"case-study","link":"https:\/\/caiready.com\/life-sciences\/case-study\/mdr-compliance-project\/","title":{"rendered":"MDR Compliance Project"},"content":{"rendered":"\n
<\/path><\/mask><\/defs><\/image><\/path><\/g><\/path><\/g><\/path><\/g><\/feFlood><\/feColorMatrix><\/feOffset><\/feGaussianBlur><\/feComposite><\/feColorMatrix><\/feBlend><\/feBlend><\/filter><\/feFlood><\/feColorMatrix><\/feOffset><\/feGaussianBlur><\/feComposite><\/feColorMatrix><\/feBlend><\/feBlend><\/filter><\/feFlood><\/feColorMatrix><\/feOffset><\/feGaussianBlur><\/feComposite><\/feColorMatrix><\/feBlend><\/feBlend><\/filter><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/div>
\n

MDR Compliance Project<\/h1>\n\n\n\n
\n
Download the PDF<\/a><\/div>\n<\/div>\n<\/div><\/div><\/div><\/div>\n\n\n\n
<\/div>
\"\"<\/div>
\n
\n
\n

PROJECT OVERVIEW<\/h2>\n\n\n\n

CAI assisted a confidential medical device manufacturer in Tbilisi, Georgia, to achieve compliance with the new Medical Device Regulation (MDR). The project spanned approximately 1.5 years and involved a comprehensive overhaul of the client’s Quality Management System (QMS). CAI conducted an initial gap assessment, designed a project roadmap and led multiple workstreams to address identified gaps. The team updated all company processes, developed new procedures and templates and guided the client through the Notified Body application process. As a result, the client established a new quality culture, opened new markets and improved their products while achieving MDR compliance.<\/p>\n\n\n\n

Topics covered<\/h2>\n\n\n\n
    \n
  • MDR gap assessment and compliance strategy<\/li>\n\n\n\n
  • QMS adaptation and process improvement<\/li>\n\n\n\n
  • Development of MDR-compliant procedures and templates<\/li>\n\n\n\n
  • Technical file creation for product information<\/li>\n\n\n\n
  • Regulatory strategy revision and Notified Body application support<\/li>\n\n\n\n
  • Clinical studies, biocompatibility and sterilization validation updates<\/li>\n\n\n\n
  • Quality culture transformation in medical device manufacturing<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
    \n
    <\/div>
    \n

    CATEGORY:<\/h3>\n\n\n\n

    Compliance & Regulatory Issues<\/p>\n\n\n\n

    CLIENT:<\/h3>\n\n\n\n

    Medical Manufacturer<\/p>\n\n\n\n

    LOCATION:<\/h3>\n\n\n\n

    Tblisi, Georgia<\/p>\n\n\n\n

    Contract Size:<\/h3>\n\n\n\n

    N\/A<\/p>\n<\/div><\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

    CAI started its collaboration with the client in 2019 originating from personal contacts of CAI agents. During this time, CAI delivered more than 350k\u20ac of projects focused mainly on quality, compliance, and regulatory affairs. The MDR compliance project cost about 200k\u20ac.<\/p>\n","protected":false},"featured_media":375594,"template":"","meta":{"_acf_changed":true},"categories":[820],"resource-category":[271],"resource-featured-status":[],"resource-type":[268],"class_list":["post-375587","case-study","type-case-study","status-publish","has-post-thumbnail","hentry","category-compliance-regulatory-issues","resource-category-compliance-regulatory-issues","resource-type-case-studies"],"acf":[],"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/case-study\/375587","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/case-study"}],"about":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/types\/case-study"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media\/375594"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media?parent=375587"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/categories?post=375587"},{"taxonomy":"resource-category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-category?post=375587"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-featured-status?post=375587"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-type?post=375587"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}