Christchurch, New Zealand, June 18, 2007
ARANZ Medical Limited, an innovator in advanced wound assessment technology, today announced that it has received ISO 13485 certification for its quality system. This complements the ISO 9001 certification that the company has held since its inception.
ISO 13485 is a standard specific to medical device quality systems. When compared to ISO 9001, ISO 13485 specifies additional requirements related to design controls, risk management, environmental controls, special processes (e.g. software validation), traceability, record retention, and regulatory actions, which are critical for the medical device industry.
“Receiving ISO 13485 certification is a major step in our goal of developing and supplying leading medical devices for global markets,” notes Dr Rick Fright, Vice President, Research and Development at ARANZ Medical Limited. “At every stage in the development and manufacturing process of our products, from the very first conceptualization of the idea through delivering product to market, we focus on quality. This ensures our customers receiving a quality product that meets their needs.”
The Silhouette product suite marketed by ARANZ Medical has been developed and is manufactured following the company’s quality system. Silhouette is an advanced and comprehensive system for wound imaging, measurement and documentation.
“Silhouette is an innovative product concept that is dramatically improving the ease and accuracy with which wounds are measured and documented,” says Dr Mark Nixon, Chief Medical Officer at ARANZ Medical Limited. “Working with wound care professionals we have developed Silhouette, an innovative portable computer device with custom camera and software that allows a medical professional to easily capture and analyze information about a wound at the point of care. This wound information is then transferred to a central database and can be shared with other health information systems. Basing these developments on a ISO 13485 certified process gives us, and our customers, confidence in the quality of the solution.”