Quality Magazine

Allied Vision Technologies Achieves ISO 13485 Certification for Medical Equipment

March 2, 2012

STADTRODA, GERMANY-Machine vision camera manufacturer Allied Vision Technologies (AVT) now complies with the ISO 13485:2010 standard for the development and production of digital cameras and components used for image processing in medical devices. The company’s quality management system was successfully audited by Eurocat Institute for Certification and Testing in November 2011 and the certificate delivered early February 2012. The scope of the certification covers the whole product life cycle from design to service and repair via manufacturing and sales.

Medical imaging has been a key market for AVT for years. With applications such as ophthalmology, microscopy, dental imaging, 3-D scanning or motion capture for orthopedic diagnosis, AVT has established a strong reputation in the medical device market, which has become a major sales area beyond industrial inspection.

“Although we have been complying to the highest quality standards for years and enjoy a very good reputation in the industry, we felt it was time to have not only the ISO 9001 certificate but also the ISO 13485 certificate for medical devices in place”, explains Dr. Volker Hartman, total quality manager of Allied Vision Technologies. “This validation according to an international standard will help us win even more medical business in our growth markets Asia and the Americas.”