Inyx Inc has received ISO 9001 accreditation, which covers the development, manufacture and supply of medical devices.
ISO 9001 accreditation means that a company has maintained a thorough and up-to-date system for manufacturing and control, which meets the international quality standards required by the European Union regulatory authorities for the marketing of medical devices in Europe and other international markets, including the United States.
Steven J. Handley, president of Inyx, said: "We are proud to report that we have been granted ISO 9001 accreditation, which bears witness to the high quality of our manufacturing standards. As a consequence, Inyx is now permitted to mark medical devices that we develop and manufacture with the CE mark, a requirement to sell these products in Europe. In addition, the granting of this certification permits Inyx to develop new medical devices and enter new international markets. As previously announced, the development of our own products, in conjunction with some of our key strategic clients, is one of our main strategies moving forward. The ISO 9001 accreditation will allow us to effectively implement this strategy in the medical device sector and allow us to enhance our international revenue base."
Inyx is currently manufacturing three products that require ISO certification: a sterile saline aerosol for contact lens use; a sterile buffered saline aerosol for contact lens use; and a sterile saline aerosol for wound irrigation. On a worldwide basis, the saline solution market for contact lenses is estimated to be upwards of $100 million, while that of wound irrigation is estimated at approximately $450 million.