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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 analyse 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.” ARANZ Medical Limited is a member of the ARANZ Group of companies (www.aranz.com) focused on the development of the Silhouette™ suite of products for wound imaging, measurement and documentation. Silhouette resulted from listening to and working with customers, recognising that a simple technology-based solution could be created that would allow more efficient wound assessment with superior outcomes. For additional information, visit our website at www.aranzmedical.com. The ARANZ Group of companies (www.aranz.com) has the vision of developing technology based solutions to solve customers’ problems in differing application areas. To date the group has demonstrated technical and commercial success in application areas as diverse as 3D modeling (see www.farfieldtechnology.com), laser surface scanners (see www.fastscan3d.com), data collection for movie making special effects, custom orthotics and prosthetics (see www.hanger.com), and geological data interpretation (see www.leapfrog3d.com). All trademarks appearing in this release are the property of ARANZ Medical. Contact: |
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.