Quality & Compliance

At CVAid, quality is a core value. CVAid 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.  CVAid has been certified for ISO 13485:2016, which ensures our medical devices meet all quality requirements.

CVAid manufactures and distributes tele-stroke 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 CVAid holds business. For information on CVAid’s products, listed solutions, safe and correct usage and indications for use, please refer to FDA’s website and to the respective device user guide.

Indications for use and important user information for CVA Flow Connect: CVAid’s triage and communication medical devices are not diagnostic software and are not intended to replace a clinician’s diagnosis per standard of care.