{"id":14311,"date":"2019-12-03T16:26:47","date_gmt":"2019-12-03T16:26:47","guid":{"rendered":"https:\/\/oxfordcorp.com\/?p=14311"},"modified":"2023-10-12T18:28:11","modified_gmt":"2023-10-12T18:28:11","slug":"compliance-review-for-medical-device-manufacturer","status":"publish","type":"post","link":"https:\/\/www.oxfordcorp.com\/es\/insights\/case-study\/compliance-review-for-medical-device-manufacturer\/","title":{"rendered":"Compliance Review for Medical Device Manufacturer"},"content":{"rendered":"<p><em>Discover how Oxford\u2019s team quickly helped capture and address issues to achieve full compliance.\u00a0<\/em><\/p>\n<p><strong>INDUSTRY<\/strong><br \/>\nMedical Device<\/p>\n<p><strong>SERVICES<\/strong><br \/>\nRemediation<br \/>\nCorrective &amp; Preventative Action (CAPA)<\/p>\n<p><strong>SKILLS<\/strong><br \/>\nFDA Compliance<br \/>\nGage R&amp;R<br \/>\nReceiving Inspection Review<br \/>\nTest Method Validation<br \/>\nCalibration and Metrology<\/p>\n<p><strong>The Challenge<\/strong><br \/>\nA medical device manufacturer needed to complete a retrospective review of the tools used on their manufacturing floor as a part of their response to an FDA inspection observation. Although only a few pieces of equipment\/tools were identified in the observation, our Oxford team recommended that the manufacturer expand their review across the entire facility to understand whether or not they had a systemic issue. Together, they opened a Corrective Action\/Preventive Action plan (CAPA) to document their actions, findings and results.<\/p>\n<p><strong>The Solution<\/strong><br \/>\nWe identified four consultants and had them ready to work on site within two weeks. Rapid and thorough completion of all activities was mission critical as production was halted during the project.<\/p>\n<p>Our Oxford project team completed extensive reviews of the client\u2019s state of compliance surrounding Gage R&amp;R studies, Receiving Inspection Forms and Test Method Validation Qualifications for every piece of equipment\/tool utilized in the production of their products. In order to capture all instances of non-compliance, our Oxford team created a Trace Matrix for our client. The team also assisted with creating a more robust Gage R&amp;R program, a Calibration program and a thorough \u201cspecial\u201d process validation program.<\/p>\n<p><strong>The Result<\/strong><br \/>\nOur Oxford team enabled our client to become compliant with company and industry requirements, thus enabling production to resume. Following the project, a subsequent FDA inspection resulted in zero FDA Form 483 observations. The Trace Matrix and CAPA that our team completed allowed the manufacturer to successfully demonstrate compliance with Quality Management System requirements and Industry Regulations.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Discover how Oxford\u2019s team quickly helped capture and address issues to achieve full compliance.\u00a0 INDUSTRY Medical Device SERVICES Remediation Corrective [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":15283,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[181],"tags":[114],"category-tag":[],"class_list":["post-14311","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","tag-healthcare"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Compliance Review for Medical Device Manufacturer - Oxford Global Resources<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/compliance-review-for-medical-device-manufacturer\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Compliance Review for Medical Device Manufacturer\" \/>\n<meta property=\"og:description\" content=\"Discover how Oxford\u2019s team quickly helped capture and address issues to achieve full compliance.\u00a0 INDUSTRY Medical Device SERVICES Remediation Corrective [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/compliance-review-for-medical-device-manufacturer\/\" \/>\n<meta property=\"og:site_name\" content=\"Oxford Global Resources\" \/>\n<meta property=\"article:published_time\" content=\"2019-12-03T16:26:47+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-10-12T18:28:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2019\/12\/compliance-review-for-medical-device-manufacturer_1.jpeg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"516\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Luke Summers\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Luke Summers\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/compliance-review-for-medical-device-manufacturer\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/compliance-review-for-medical-device-manufacturer\\\/\"},\"author\":{\"name\":\"Luke Summers\",\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/de\\\/#\\\/schema\\\/person\\\/e880f6edc6bcf421204f294431943cd3\"},\"headline\":\"Compliance Review for Medical Device Manufacturer\",\"datePublished\":\"2019-12-03T16:26:47+00:00\",\"dateModified\":\"2023-10-12T18:28:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/compliance-review-for-medical-device-manufacturer\\\/\"},\"wordCount\":307,\"image\":{\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/compliance-review-for-medical-device-manufacturer\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.oxfordcorp.com\\\/wp-content\\\/uploads\\\/2019\\\/12\\\/compliance-review-for-medical-device-manufacturer_1.jpeg\",\"keywords\":[\"Healthcare\"],\"articleSection\":[\"Case Study\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/compliance-review-for-medical-device-manufacturer\\\/\",\"url\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/compliance-review-for-medical-device-manufacturer\\\/\",\"name\":\"Compliance Review for Medical Device Manufacturer - 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