Guava Technologies (Hayward, California), an on-demand, benchtop cell analysis systems company, reported that it was successfully audited to the requirements of ISO13485:2003 by BSI Management Systems. With this certification, the company will redouble efforts on medical devices for the international market, covering a variety of therapy areas, beginning with HIV/AIDS.

ISO is a network of the national standards institutes of 157 countries, and ISO 13485 is an internationally recognized standard to establish the quality management systems applicable to manufacturers of medical devices. It is harmonized to FDA 21 CFR part 820.

“We are proud to receive this international recognition,” said Lawrence Bruder, president/CEO. “It’s a clear indication of our ability to consistently meet regulatory and customer requirements for medical devices, and reflects our intense commitment to the highest possible standards for design, development, manufacture, and service for all of our products.”

“ISO certification was the first step in our initiatives to deliver quality medical devices to the global healthcare community,” continued Bruder. “We can now focus on international commercialization of our new CD4 T-cell System for monitoring treatment of HIV/AIDS.”