Medical technology firm Cairn Surgical has received ISO 13485:2016 certification for its Quality Management System associated with a 3D printing-enabled Breast Cancer Locator (BCL) System.
ISO 13485 is the international standard for quality management systems in the medical device industry and represent a significant step forward for Cairn Surgical.
Cairn Surgical is striving to make breast cancer surgery more precise and has developed the BCL System to improve the accuracy of breast conserving surgery (lumpectomy) by providing precise guidance regarding tumour shape, size, and location. The BCL System is made up of two components, one of which is a customised 3D printed form that fits the unique shape of the patient's breast and marks the tumour’s boundaries. This and a second component are created from a supine MRI of the patient’s breast, with the breast positioned in its surgical position for greatest accuracy. An interactive, real-time image of the tumour in the breast is also produced – the Visualizer – providing a detailed, 3D view of the tumor within the breast. During surgery, the two technologies are used concurrently by a surgeon to provide invaluable references during tumour excision.
“ISO certification is an important step in the evolution of the company as we look towards broader commercialization of the BCL System in Europe and entrance into new regions,” said Cairn Surgical CEO David Danielsen. “It demonstrates not only our commitment to product quality, but also our ability to achieve it consistently across the design, development and manufacturing of our BCL System, and compliance with all applicable regulatory requirements. We look forward to the momentum this milestone will bring to our regulatory and market access efforts.”
Cairn Surgical is now undertaking a U.S. pivotal trial of the BCL System, which is expected to be completed later this year.
