PhotoniCare, a medical device firm specializing in pediatric middle ear solutions, enlisted the expertise of Rook Quality Systems in August 2023 to aid in preparing their OtoSight Middle Ear Scope for FDA approval. 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. PhontiCare’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.
FDA inspections are meticulous and crucial, demanding significant time and effort from both medical device manufacturers and quality consultants. When PhotoniCare approached Rook, they required urgent assistance with various quality-related tasks, including preparing for the FDA inspection, receiving FDA training, enhancing their Quality Management System (QMS), and obtaining quality consulting support.
Scope of Work
In mid-August, the RookQS team collaborated with PhotoniCare, and shortly thereafter, the company received notice of an impending FDA inspection scheduled just a week after partnering with RookQS. This tight timeline left PhotoniCare with minimal preparation time, necessitating urgent assistance in preparing their Quality Management System (QMS) for the impending FDA audit.
The Rook Quality Consultant assigned to the PhontiCare project worked tirelessly, dedicating full-time effort to preparing PhontiCare for the impending FDA inspection. Our consultant collaborated closely with the PhontiCare team throughout the weekend leading up to the inspection, ensuring comprehensive readiness for the FDA’s visit the following Monday. Recognizing the considerable stress associated with FDA audits, the Rook team remains committed to offering continuous, round-the-clock support to alleviate client anxieties during these critical assessments.
Despite the tight timeline, the FDA audit yielded only three observations, two of which were promptly rectified with Rook’s guidance before the audit’s conclusion. The FDA inspector lauded Rook’s involvement and support, particularly given the short notice. Following the successful audit response, PhotoniCare elected to retain RookQS’s services for ongoing quality consulting. With FDA clearance obtained, the OtoSight Middle Ear Scope has revolutionized the industry, and RookQS continues to provide tailored quality support to PhotoniCare.