Cairn Surgical Inc., which is developing technology designed to make breast cancer surgery more precise, has received ISO 13485:2016 certification for the quality management system associated with the its Breast Cancer Locator System, the Lebanon company announced Thursday.
ISO 13485 is the international standard for quality management systems in the medical device industry, Cairn said.
A visualizer image from Cairn Surgical’s Breast Cancer Locator System. (Courtesy of Cairn Surgical)
“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,” Cairn Surgical CEO David Danielsen said in a press release.
The Breast Cancer Locator — which was won the NH Tech Alliance’s Product of the Year in 2021 — was developed in part by Keith D. Paulsen, a professor of engineering at Dartmouth and co-director of the Translational Engineering in Cancer research program at the Norris Cotton Cancer Center, along with Dartmouth-Hitchcock surgical oncologist Richard J. Barth Jr., a member of the TEC.
The BCL System is designed to improve the accuracy of breast conserving surgery, also known as lumpectomy, by providing precise guidance of the shape, size and location of tumors, the company said. It involves creating two components from a MRI of the patient’s breast: a customized 3D-printed form that fits the shape of the breast and mark’s the tumor’s boundaries, and an interactive 3D view of the tumor within the breast. Surgeons use both technologies during surgery.
The certification demonstrates the company’s commitment to product quality and its ability to “achieve it consistently across the design, development and manufacturing of our BCL System, and compliance with all applicable regulatory requirements,” Danielson said.
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Lebanon company’s breast cancer locator won the nh tech alliance’s product of the year in 2021
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Cairn Surgical Inc., which is developing technology designed to make breast cancer surgery more precise, has received ISO 13485:2016 certification for the quality management system associated with the its Breast Cancer Locator System, the Lebanon company announced Thursday.
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