Our quality system is ISO 13485:2003 certified for design, manufacture, marketing and sales of medical devices. The ISO system operates as a structured framework for quality management practices and it is becoming a standard requirement for companies.
ISO certification means that Optomed is in compliance with the ISO quality requirements for design and production of medical devices and also with regulatory requirements for selling and marketing medical products. Optomed’s customers can be assured that Optomed’s quality management system conforms to the International Organization for Standardization’s guidelines and is audited annually by an independent external company for continued compliance.