Here are just a few examples of how we led our clients on the path to success!
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 client, A Wright Path® created a new quality management system suitable for the company’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.
A Wright Path® was approached by a small medical device manufacturer who was searching for quality and regulatory support to not only function as a part of their project teams, but also to maintain daily quality and regulatory functions. After a review of the company’s existing system, A Wright Path® designed an efficient and 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 to 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.
A medical device implant company approached A Wright Path after other advisors failed to implement a quality solution. Facing a dire situation, A Wright Path consultants jumped in and developed a strategy, and then implemented a Quality System in under than three months. After completing their DHF remediation and QMS requirements to the Quality Management System (and once their 510K cleared), this relieved client’s product was ready for commercialization. Afterwards, 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 large medical device company consulted A Wright Path after receiving an FDA inspection that resulted in FDA 483s. Immediately, A Wright Path took action 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 client’s Quality System procedures based on the Gap Analysis and FDA requirements.