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!
A WRIGHT PATH GUIDES MANUFACTURERS IN 510(k) CLEARANCE OF SEQUENTIAL ALIGNERS
A small medical device company recently contacted A Wright Path after its customer uncovered several non-conformances following an audit. This company is a supplier to a large medical device manufacturer and had failed in several compliances according to 21 CFR Part 820. A Wright Path quickly designed a path to achieve a full compliance solution, effectively responding to the uncovered non-conformances.
For one of the dental labs, our team created a regulatory strategy, which identified the necessary testing required for the 510(k) submission. After drafting the 510(k), the clients were pleased with the submission 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 (Food and Drug Administration) in less than seven weeks.
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 submission. After submitting the 510(k), A Wright Path successfully addressed FDAâ€™s questions and achieved FDA clearance for their clientâ€™s sequential aligners.While working with these clients, our A Wright Path team of regulatory consultants was able to gain valuable insight into the latest FDA 510(k) submission requirements for sequential aligner manufacturers, adding to our vast portfolio of regulatory expertise!
A MEDICAL DEVICE COMPANY'S PATH TO CONFORMANCE
A small medical device company recently contacted A Wright Path after its customer uncovered several non-conformances following an audit. This company is a supplier to a large medical device 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.
While working closely with a client, A Wright Path created a new quality management system suitable for the companyâ€™s operations and implemented the system within a time frame acceptable to the auditing customer. A Wright Path partnered with the medical device company while they trained, implemented, and operated the new quality system.
SURGICAL DEVICE MANUFACTURERâ€™S PATH LEADS TO MARKETING THEIR PRODUCT SAFELY IN THE US
A Wright Path was approached by a small medical device manufacturer searching for a consulting firm to offer quality and regulatory support. They needed a firm to function as a part of their project teams, and also to maintain daily quality and regulatory requirement functions. After a review of the companyâ€™s existing system, A Wright Path designed an efficient and cost-effective quality system that would be best for this manufacturer.
Partnering with the company, A Wright Path quickly implemented the new quality system and continues daily quality and regulatory support functions. This support includes CAPA initiation and monitoring, supplier evaluations, approvals and auditing, non-conforming product control, ECR implementation/document control, and overall compliance with the new quality system and FDA requirements. These efforts by A Wright Path have allowed the manufacturer to now market their product within the US.
YOUR SUCCESS STORY HEREâ€¦
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.
A WRIGHT PATH RESCUES COMPANY AFTER PREVIOUS CONSULTANTS FAIL
A medical device implant company approached A Wright Path after other advisors failed to implement an on-site quality solution. Facing a dire situation, A Wright Path consultants jumped in and developed a strategy, and then implemented a Quality System in under three months. After completing their DHF remediation and QMS requirements to the Quality Management System (and once their 510K cleared), this relieved clientâ€™s product was ready for commercialization. Afterward, A Wright Path handled additional requests successfully with the FDA and now manages their daily Quality Assurance and Regulatory Affairs function, as well as Microbiological and Sterilization Support.
A WRIGHT PATH EXECUTES CRISIS MANAGEMENT TO AID LARGE MEDICAL DEVICE COMPANY
A large medical device company consulted A Wright Path after receiving an FDA inspection that resulted in a warning letter, 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 medical device 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 Quality System Gap Analysis based on the 483 response, making recommended changes and revising the clientâ€™s Quality System procedures based on the Gap Analysis and FDA requirements.
If youâ€™re considering working with FDA compliance consultants, give A Wright Path a call! Weâ€™re a trusted name in regulatory strategy and can navigate your path to FDA and worldwide compliance. Weâ€™ll get you on the Right Path, Right Now! Schedule a consultation today.Â