Certified Quality System
As we embark on a new season of product innovations, watch for our exciting new updates. As an ISO 13485 certified and FDA registered medical device manufacturer of products for instrument processing, we are proud to announce that Case Medical is now ISO 27001 Certification for its development of CaseTrak360® software.
This certification means that our software platform has undergone a rigorous independent audit, conform to the highest quality standards, and that our information security practices are certified to meet international standards.
At Case Medical, we understand the importance of infection prevention and traceability, which is why we developed CaseTrak360®, an asset management system that increases communication between SPD and the OR by tracking instrument sets and loaner trays in real time. We have also implemented UDI labeling and installed laser marking equipment for further direct product identification, meeting FDA requirements for direct marking of all Class II devices. To learn more about our software systems or labeling capabilities, contact us today at firstname.lastname@example.org.