Medical know-how agency Cairn Surgical has obtained ISO 13485:2016 certification for its High quality Administration System related to a 3D printing-enabled Breast Most cancers Locator (BCL) System.
ISO 13485 is the worldwide normal for high quality administration methods within the medical system trade and characterize a major step ahead for Cairn Surgical.
Cairn Surgical is striving to make breast most cancers surgical procedure extra exact and has developed the BCL System to enhance the accuracy of breast conserving surgical procedure (lumpectomy) by offering exact steerage relating to tumour form, measurement, and site. The BCL System is made up of two elements, one in all which is a personalized 3D printed type that matches the distinctive form of the affected person’s breast and marks the tumour’s boundaries. This and a second element are created from a supine MRI of the affected person’s breast, with the breast positioned in its surgical place for best accuracy. An interactive, real-time picture of the tumour within the breast can be produced – the Visualizer – offering an in depth, 3D view of the tumor throughout the breast. Throughout surgical procedure, the 2 applied sciences are used concurrently by a surgeon to supply invaluable references throughout tumour excision.
“ISO certification is a vital step within the evolution of the corporate as we glance in the direction of broader commercialization of the BCL System in Europe and entrance into new areas,” stated Cairn Surgical CEO David Danielsen. “It demonstrates not solely our dedication to product high quality, but in addition our means to realize it constantly throughout the design, growth and manufacturing of our BCL System, and compliance with all relevant regulatory necessities. We sit up for the momentum this milestone will convey to our regulatory and market entry efforts.”
Cairn Surgical is now enterprise a U.S. pivotal trial of the BCL System, which is predicted to be accomplished later this 12 months.
