Unomedical's Quality Policy and commitments are in place to provide cost effective quality products for global health care professionals. We aim to become the preferred supplier for all our customers through offering high level of quality for all our products and supporting services.
Our production facility is registered with various Health Authorities throughout the world : US FDA, Canada Health Authority, Japan MOH and China SDA.
Our entire Quality Management System is in compliance to US FDA Quality System Regulations (QSR) requirements, EN ISO 13485:2003 quality system standards, European Medical Device Directive 93/42/EEC and Canadian Medical Devices Regulations.
The company has been inspected by US FDA Inspectors more than 7 times since 1990, with no observations issued.
Despite our excellent track record, we are working hard to further enhance our Quality System to meet the growing demands from World Class International Standards.