{"id":14306,"date":"2019-11-14T22:17:50","date_gmt":"2019-11-14T22:17:50","guid":{"rendered":"https:\/\/oxfordcorp.com\/?p=14306"},"modified":"2023-10-12T18:27:00","modified_gmt":"2023-10-12T18:27:00","slug":"compliance-combination-products","status":"publish","type":"post","link":"https:\/\/www.oxfordcorp.com\/fr\/insights\/case-study\/compliance-combination-products\/","title":{"rendered":"Compliance for Combination Products"},"content":{"rendered":"<p><em>Discover how Oxford helped our client qualify 50 combination products in 3 years.<\/em><\/p>\n<p><strong>INDUSTRY<\/strong><br \/>\nPharmaceutical<br \/>\nMedical Device Manufacturer<\/p>\n<p><strong>SERVICES<\/strong><br \/>\nCommissioning &amp; Qualification<br \/>\nProduct Development<br \/>\nRemediation<\/p>\n<p><strong>SKILLS<\/strong><br \/>\nISO Compliance<br \/>\nProject Management<br \/>\nTest Method Validation<\/p>\n<p><strong>The Challenge<\/strong><br \/>\nA large pharmaceutical organization formed a new device-manufacturing division and requested Oxford\u2019s support in achieving compliance for a brand new range of combination products. The scope of the project required a large group of consultants to assist the client with preparing new product lines to be compliant with ISO 13485, ISO 14971, and 21 CFR Part 820. Several project leaders were also required to manage the development of more than 50 products within their portfolio of drug-delivery services. Our client needed the right partner to help accelerate the development lifecycle and get their products to market more quickly.<\/p>\n<p><strong>The Solution<\/strong><br \/>\nThrough a careful vetting process, Oxford placed over 40 senior-level consultants, each holding a minimum of seven to eight years of experience, with knowledge in both pharmaceuticals and medical devices. We provided experts with an in-depth understanding of medical device compliance, and the ability to execute a hands-on approach to meet project deliverables. Our team supported the development of various combination products, including: pre-filled syringes, autoinjectors, subcutaneous patches, pumps, dry powder and metered dose inhalers.<\/p>\n<p>Project workstreams covered:<\/p>\n<ul>\n<li>Material selection and supplier engagement<\/li>\n<li>Human Factors Engineering (IEC62366) and ISO 13485 compliance<\/li>\n<li>Design History File (DHF) remediation (legacy products) and compilation (new devices)<\/li>\n<li>Design Control (input, output, testing &amp; verification) and implementation of 21 CFR 820 Part 4<\/li>\n<li>Improving the level of ISO 14971 compliance within this combination-product business unit<\/li>\n<\/ul>\n<p><strong>The Result<\/strong><br \/>\nAll project goals and requirements were successfully reached. Over a four-year period, our client retained all 40 consultants. The consultant team was so effective that each person received a six or 12-month expansion on their contract. Working in close collaboration, we helped qualify and deliver 50 new combination products to market within two to three years.<\/p>\n<p>By evaluating requirements, providing the right high quality candidates, and maintaining ongoing communication throughout the project, Oxford became a preferred partner, with multiple consultants actively supporting new and ongoing objectives within this device-manufacturing business unit.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Discover how Oxford helped our client qualify 50 combination products in 3 years. INDUSTRY Pharmaceutical Medical Device Manufacturer SERVICES Commissioning [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":15348,"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":[113],"category-tag":[],"class_list":["post-14306","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","tag-life-sciences"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.1 (Yoast SEO v27.1.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Compliance for Combination Products - Oxford<\/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-combination-products\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Compliance for Combination Products\" \/>\n<meta property=\"og:description\" content=\"Discover how Oxford helped our client qualify 50 combination products in 3 years. 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