Quality & Compliance
Last Updated: February 2022
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.
Our Regulatory Affairs department manages registrations and listings with the FDA and all other regulatory authorities in territories in which Aidoc holds business.
Aidoc’s triage and notification solutions 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.
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.