Toltec International, Inc. benefits our clients in the medical device industry by assisting in their research and development efforts. With extensive experience in project management, real-time embedded software, hardware, and mechanical engineering, we add value to those companies undertaking new medical device projects or improving medical devices already on the market. Because of our long experience and knowledge gained working under FDA/cGMP, ISO 9000, and IEC standards, the professionals at Toltec dramatically reduce the time it takes to get products on the market. We are particularly strong in the area of devices involving extracorporeal, hydraulic components, and the real-time control of these devices. We can help assure machine safety through the adherence to standards such as FDA Quality System Regulation 21 CFR Part 820 Medical Devices; Current Good Manufacturing Practice (CGMP) and IEC 601-1 Medical Electrical Equipment
