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 QUALIRA 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), QUALIRA successfully addressed FDA’s questions and achieved FDA clearance for their client’s sequential aligners. While working with these clients, our QUALIRA 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 small medical device company recently contacted QUALIRA after an audit by its customer uncovered several non-conformances. As a supplier to a large medical device manufacturer, it was imperative to resolve the 21 CFR Part 820 non-compliance issues quickly. QUALIRA was expeditious in designing a path to achieve a full compliance solution, effectively responding to the uncovered non-conformances. While working closely with the client, QUALIRA 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. QUALIRA partnered with the medical device company while they trained, implemented, and operated the new quality system.

QUALIRA 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 to maintain daily quality and regulatory requirement functions. After a review of the company’s existing system, QUALIRA designed an efficient and cost-effective quality system that would be best for this manufacturer. Partnering with the company, QUALIRA 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 QUALIRA have allowed the manufacturer to now market their product within the US.

When a medical device implant company faced setbacks from prior consultants, they called on QUALIRA to salvage a precarious situation. Our consultants devised and executed a rigorous on-site quality strategy within three months, completing DHF remediation and QMS compliance. Upon obtaining their 510(k) clearance, the company launched its product for commercialization. Today, QUALIRA continues to manage their daily Quality Assurance, Regulatory Affairs, and Microbiological and Sterilization Support, maintaining their trajectory of success.

A large medical device company consulted QUALIRA after receiving an FDA inspection that resulted in a warning letter, also known as an FDA 483. Immediately, QUALIRA acted and drafted the 483 Response to the FDA which was accepted with no additional requirements on the proposed corrective actions. QUALIRA 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. By conducting a thorough Quality System Gap Analysis, QUALIRA initiated pivotal improvements to the company’s Quality Systems aligning with FDA standards, strengthening the company’s compliance infrastructure.

Qualira was approached by a client to provide assistance with an ongoing medical device clinical study. Qualira provided expert integrated clinical and regulatory guidance to assess the current study conduct and complete a gap analysis. Corrective measures were quickly applied to remediate data collection concerns and bring the study into compliance. With this successful remediation, the client expanded the scope of work to include engaging Qualira for clinical trial management services. Qualira created clinical operating procedures and implemented a documentation system to conduct the clinical study. Clinical trial management services include: Protocol Development, Electronic Data Capture (EDC) support and user acceptance testing (UAT) of EDC updates; IRB Submissions (including informed consent form development); clinical site management (site evaluation, initiation, monitoring oversight, close-out); clinical monitoring plan, study plan, and study document development; data export review and query generation; site contract and budget negotiations; study training; clinical study reports; and support manuscripts for peer-reviewed literature. Qualira continues to provide expert clinical guidance and clinical trial management services to the client.

A client contacted Qualira with a plan to conduct a clinical trial with novel device. The client requested Qualira to submit a rough draft of a clinical protocol in a Pre-Submission (Q-Submission) to the FDA for feedback. Qualira carefully navigated through the device information and provided the client with advice for a different approach, leveraging their integrated clinical and regulatory expertise. Qualira suggested an alternative pathway by first submitting a 513(g) for a classification designation followed by a Pre-Submission with the FDA. The 513(g) submission resulted in FDA’s recommendation for a De Novo rather than a PMA submission. At the Pre-Submission meeting, Qualira was successful in obtaining FDA’s agreement to move forward with animal study data rather than clinical data with an IDE clinical trial, resulting in significant cost and time-saving for the client.