April 24, 2019 -- Breast imaging software developer Volpara Solutions has received Medical Device Single Audit Program (MDSAP) 690110 certification for the U.S., Canada, Japan, and Australia for the design, development, delivery, and support of the company's software.
MDSAP evaluates a medical device manufacturer's quality management system to ensure that it meets the requirements of regulatory agencies participating in the program. The agencies include Australia's Therapeutic Goods Administration (TGA), Health Canada, the U.S. Food and Drug Administration (FDA), and Japan's Ministry of Health, Labour, and Welfare.
Volpara's software is designed for facilities to perform quality control checks to optimize productivity and efficiency of imaging resources. One of the clinical applications within VolparaEnterprise is VolparaDensity, which allows radiologists to perform automated volumetric breast density assessments and provides a breast density category shown to correlate to BI-RADS fourth and fifth editions. It has received clearance from the FDA, the CE Mark from the European Union, and approvals from Health Canada and the TGA.
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