Quality & Compliance
Last Updated: January 2023
At Aidoc®, exceptional quality is a core value. Our Quality Management System for managing the company’s different operations is designed in accordance with the framework established by the FDA Quality System Regulation (21 CFR Part 820) and ISO 13485. Aidoc has been certified for ISO 13485:2016, which ensures our medical devices meet all quality requirements.
Aidoc manufactures and distributes AI image based medical devices, and non-medical device (report-based) solutions.
Our Compliance department manages registrations and listings with the FDA, and all other regulatory authorities, in territories in which Aidoc holds business. For information on Aidoc’s products, cleared solutions, safe and correct usage and indications for use, please refer to Aidoc’s 510(k) premarket notifications on FDA’s website and to the respective device user guide.
Indications for use and important user information for BriefCase-Triage: Aidoc’s triage and notification medical devices are not diagnostic software and are not intended to replace a clinician’s full interpretation of a medical image per standard of care. Clinical decisions should be taken only after evaluating the full original series in the PACS as well as other relevant information.