Danbury, CT--TOPEX, Inc. has received ISO 13485:2003 certification as a manufacturer of superficial x-ray therapy systems designed to treat skin cancer. This certification serves as recognition for the TOPEX Quality System meeting the requirements on the International Quality Standards for Medical Devices.

"This was a great effort by the entire TOPEX team," said Anthony Pellegrino, CEO for TOPEX, Inc. "This validates our quality system and demonstrates we are providing top performing skin cancer treatment systems for physicians and the patients they serve."

To obtain this performance distinction, a certified organization assessed TOPEX's internal systems and processes to insure the ISO quality management standards were met. These include the company's overall quality program, management controls, technical product development procedures, documentation controls, internal processes and procedures, customer service, and other requirements that comprise quality management excellence. During 2007, the company received FDA market clearance and the European CE mark.
TOPEX, Inc. is a medical device technology company located in Danbury, CT and focused on the design, manufacture and global distribution of a unique mobile superficial x-ray system developed specifically for the treatment of skin cancer.

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