We are a development-stage manufacturer of minimally invasive endovascular medical devices for treatment of thrombosis-related conditions in the vascular system

Flow Medical is committed to meeting our customers’ requirements by continuously improving product performance and product quality by monitoring quality objectives, complying with all applicable worldwide standards for medical devices and maintaining the effectiveness of the company’s Quality Management System. Flow Medical Quality System complies with applicable standards and laws in the United States (US), European Union (EU) and other countries where we do business. The applicable standards include, but are not limited to: Medical Devices-Quality management systems-Requirements for regulatory purposes (ISO 13485:2016), the European Medical Device Regulation (Regulation [EU] 2017/45 of the European Parliament and Council, referred to as MDR), and the US FDA Quality System Regulations (21 CFR 820, referred to as QSR).

Beyond these necessary aspects, a Quality System relies on the dedication and excellence of the people who make up Our Company. We are proud of the great accomplishments we have achieved and will achieve together. As expressed in our mission statement we see further major developments in the years ahead.