{"id":452,"date":"2019-06-02T09:45:04","date_gmt":"2019-06-02T09:45:04","guid":{"rendered":"https:\/\/awrightpath.net\/?page_id=452"},"modified":"2023-01-27T19:29:54","modified_gmt":"2023-01-28T00:29:54","slug":"success","status":"publish","type":"page","link":"https:\/\/awrightpath.net\/success\/","title":{"rendered":"Success stories"},"content":{"rendered":"\t\t
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FDA Regulatory Compliance Success Stories<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Wondering how working with <\/span>FDA compliance consultants<\/span> can benefit you? Here are just a few examples of how our <\/span>consulting services<\/span> led our clients in <\/span>FDA-regulated industries<\/span> on the path to success! <\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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A WRIGHT PATH GUIDES MANUFACTURERS IN 510(k) CLEARANCE OF SEQUENTIAL ALIGNERS<\/span><\/span>\n<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A small <\/span>medical device company<\/span> recently contacted A Wright Path after its customer uncovered several non-conformances following an <\/span>audit<\/span>. This company is a supplier to a large <\/span>medical device<\/span> manufacturer and had failed in several compliances according to 21 CFR Part 820. A Wright Path quickly designed a path to achieve a full <\/span>compliance solution<\/span>, effectively responding to the uncovered non-conformances.<\/span><\/p>

For one of the dental labs, our team created a <\/span>regulatory strategy<\/span>, which identified the necessary testing required for the 510(k) <\/span>submission<\/span>. After drafting the 510(k), the clients were pleased with the <\/span>submission<\/span> and provided a final review and signoff. Through a third-party reviewer, the Traditional 510(k) was successfully submitted and the manufacturer gained clearance from the FDA (<\/span>Food and Drug Administration<\/span>) in less than seven weeks.<\/span><\/p>

Another manufacturer contacted A Wright Path to review their draft of an aligner 510(k). Our team provided guidance and support for improving and completing their 510(k), identifying additional testing required for the <\/span>submission<\/span>. After submitting the 510(k), A Wright Path successfully addressed FDA\u2019s questions and achieved FDA clearance for their client\u2019s sequential aligners.<\/span>While working with these clients, our A Wright Path team of <\/span>regulatory consultants was able to gain valuable insight into the latest FDA 510(k) <\/span>submission requirements for sequential aligner manufacturers, adding to our vast portfolio of <\/span>regulatory expertise!<\/span><\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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A MEDICAL DEVICE COMPANY'S<\/span> PATH TO CONFORMANCE<\/span><\/span><\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A small <\/span>medical device company recently contacted A Wright Path after its customer uncovered several non-conformances following an audit<\/span>. This company is a supplier to a large medical device <\/span> manufacturer and had failed in several compliances according to 21 CFR Part 820. A Wright Path quickly designed a path to compliance, effectively responding to the uncovered non-conformances.<\/span><\/p>

While working closely with a client, A Wright Path created a new quality management system suitable for the company\u2019s operations and implemented the system within a time frame acceptable to the auditing <\/span>customer. A Wright Path partnered with the<\/span> medical device company while they trained, implemented, and operated the new quality system.<\/span><\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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SURGICAL DEVICE MANUFACTURER\u2019S PATH LEADS TO MARKETING THEIR PRODUCT SAFELY IN THE US<\/span><\/span><\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A Wright Path was approached by a small <\/span>medical device<\/span> manufacturer searching for a <\/span>consulting firm<\/span> to offer quality and <\/span>regulatory<\/span> support. They needed a firm to function as a part of their project teams, and also to maintain daily quality and <\/span>regulatory requirement<\/span> functions. After a review of the company\u2019s existing system, A Wright Path designed an efficient and <\/span>cost-effective<\/span> quality system<\/span> that would be best for this manufacturer.<\/span><\/p>

Partnering with the company, A Wright Path quickly implemented the new <\/span>quality system<\/span> and continues daily quality and <\/span>regulatory<\/span> support functions. This support includes CAPA initiation and monitoring, supplier evaluations, approvals and <\/span>auditing<\/span>, non-conforming product control, ECR implementation\/document control, and overall compliance with the new <\/span>quality system<\/span> and <\/span>FDA requirements<\/span>. These efforts by A Wright Path have allowed the manufacturer to now market their product within the US.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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YOUR SUCCESS STORY HERE\u2026<\/span><\/span><\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Add your success story by getting on the Right Path, RIGHT NOW!! With strong and solid industry expertise, A Wright Path is YOUR trusted partner for FDA regulation compliance services.<\/span><\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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A WRIGHT PATH RESCUES COMPANY AFTER PREVIOUS CONSULTANTS FAIL<\/span><\/span><\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u00a0<\/p>

A medical device<\/span> implant company approached A Wright Path after other advisors failed to implement an on-site <\/span>quality solution. Facing a dire situation, A Wright Path consultants jumped in and developed a strategy, and then implemented a Quality System<\/span> in under three months. After completing their DHF remediation and QMS requirements to the Quality Management System (and once their 510K cleared), this relieved client\u2019s product was ready for commercialization. Afterward, A Wright Path handled additional requests successfully with the FDA and now manages their daily Quality Assurance<\/span> and Regulatory Affairs<\/span> function, as well as Microbiological and Sterilization Support.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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A WRIGHT PATH EXECUTES CRISIS MANAGEMENT TO AID LARGE MEDICAL DEVICE COMPANY<\/span><\/span><\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A large <\/span>medical device company<\/span> consulted A Wright Path after receiving an <\/span>FDA inspection<\/span> that resulted in a <\/span>warning letter<\/span>, also known as an FDA 483. Immediately, A Wright Path acted and drafted the 483 Response to the FDA which was accepted with no additional requirements on the proposed corrective actions. A Wright Path then supported this client on three <\/span>medical device<\/span> recalls by performing a Health Risk Assessment and drafting the accompanying documentation and strategy, which the FDA accepted without additional comments. A Wright Path then performed a <\/span>Quality System<\/span> Gap Analysis based on the 483 response, making recommended changes and revising the client\u2019s <\/span>Quality System<\/span> procedures based on the Gap Analysis and <\/span>FDA requirements<\/span>.<\/span><\/p>

If you\u2019re considering working with <\/span>FDA compliance consultants<\/span>, give A Wright Path a call! We\u2019re a trusted name in <\/span>regulatory strategy<\/span> and can navigate your path to FDA and worldwide compliance. We\u2019ll get you on the Right Path, Right Now! <\/span>Schedule a consultation today<\/span><\/a>.\u00a0<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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FDA Regulatory Compliance Success Stories Wondering how working with FDA compliance consultants can benefit you? Here are just a few examples of how our consulting services led our clients in FDA-regulated industries on the path to success! SCHEDULE CONSULTATION A WRIGHT PATH GUIDES MANUFACTURERS IN 510(k) CLEARANCE OF SEQUENTIAL ALIGNERS A small medical device company […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":[],"yoast_head":"\nWorking With FDA Compliance Consultant- Success Stories<\/title>\n<meta name=\"description\" content=\"Find out how A Wright Path guides our clients to regulatory success down the Right Path, Right Now!\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/awrightpath.net\/success\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Working With FDA Compliance Consultant- Success Stories\" \/>\n<meta property=\"og:description\" content=\"Find out how A Wright Path guides our clients to regulatory success down the Right Path, Right Now!\" \/>\n<meta property=\"og:url\" content=\"https:\/\/awrightpath.net\/success\/\" \/>\n<meta property=\"og:site_name\" content=\"A Wright Path | Right Path. 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