Announcement of ISO 13485:2016 certification

TracInnovations is pleased to announce its new ISO 13485:2016 certification for its medical device and quality management system within the scope of non-sterile motion tracking and correction systems for medical imaging in hospital settings for image-based diagnostics and treatments.

ISO 13485 is the quality management system standard for medical device manufacturers. Based on the ISO 9001 standard, ISO 13485 includes extra requirements for medical device manufacturers to demonstrate their intent to comply with applicable regulatory and statutory requirements. ISO 13485 is recognised as an aid in supporting compliance with the Medical Device Directive.

This milestone towards full certification is the result of a very strong team effort. It has demonstrated the commitment towards delivering the greatest quality products and services to our customers. We are profoundly proud to have achieved this medical device quality standard.