Photonicare

Premise

In August 2023, PhotoniCare, a medical device firm specializing in pediatric middle ear solutions, enlisted the expertise of Rook Quality Systems (RookQS) to prepare for FDA inspection readiness.

The company revamped the established diagnostic technology of Optical Coherence Tomography (OCT) to create the OtoSight™ Middle Ear Scope. Given the significant annual expenditure of $10 million on managing ear infections and a documented 50% misdiagnosis rate among primary care physicians, current diagnostic tools for middle ear fluid lack reliability in interpreting patient conditions.

PhotoniCare's OtoSight™ Middle Ear Scope offers a non-invasive, comprehensive assessment, aiming to eliminate subjectivity and speculation. With OtoSight™, PhotoniCare provides visibility to the invisible, revolutionizing treatment planning.

Scope of Work

Upon signing with RookQS, PhotoniCare received notice of FDA inspection. FDA inspections are meticulous and crucial, demanding significant time and effort from both medical device manufacturers and quality consultants.

When PhotoniCare approached RookQS, they wanted to implement an FDA readiness program to ensure their team was adequately prepared for an FDA inspection, including FDA inspection guidance, mock inspection and QMS review. This would not only ensure their team was adequately prepared for an FDA inspection but also promote enhanced QMS compliance.

This tight timeline left PhotoniCare with minimal preparation time, necessitating urgent assistance in preparing their Quality Management System (QMS) for the impending FDA audit.

Engagement

The Rook Quality Consultant assigned to the PhotoniCare project worked tirelessly, dedicating full-time effort to preparing PhotoniCare for the impending FDA inspection. This consultant collaborated closely with the PhotoniCare team throughout the weekend leading up to the inspection, ensuring comprehensive readiness for the FDA's visit the following Monday.

PhotoniCare utilizes the eQMS platform, Greenlight Guru, for document control, design, risk, CAPA, compliant, and nonconformance management. As RookQS consultants are very adept with this system, this enabled a streamlined full system review, in preparation, and immediate knowledge of the system to aid in document navigation during the inspection.

Recognizing the considerable stress associated with FDA audits, the RookQS team remains committed to offering continuous, round-the-clock support to alleviate client anxieties during these critical assessments.

Outcome

Despite the tight timeline, the FDA audit yielded only three observations, two of which were immediate corrections with RookQS’ guidance before the audit's conclusion. The FDA inspector lauded the RookQS team’s involvement and support, particularly given the short notice.

Following the successful audit response, PhotoniCare elected to retain RookQS services for ongoing quality consulting and internal audit support.

PhotoniCare continues to use the eQMS platform, Greenlight Guru, as they have been very satisfied with how user-friendly the platform is in comparison to other available eQMS platforms. The OtoSight Middle Ear Scope has revolutionized the industry, and RookQS continues to provide tailored quality support to PhotoniCare.