Volpara Secures Medical Device Single Audit Program (MDSAP) 690110 Certification
MDSAP Certification Satisfies ISO and Regulatory Compliance Requirements for Japan, Australia, Canada, and the United States
WELLINGTON, NZ, April 24, 2019 – Volpara Health Technologies (VHT), the industry leader in breast imaging analytics, announced today that the company has achieved MDSAP 690110 certification for Japan, Australia, Canada, and the United States. Validated by an independent auditor, the British Standards Institution (BSI), the certification covers the design, development, delivery, and support of Volpara’s software.
As outlined by the US Food & Drug Administration (FDA), MDSAP allows a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to satisfy the requirements of the regulatory agencies participating in the program. These agencies include Australia’s Therapeutic Goods Administration (TGA), Health Canada, the United States’ FDA, and Japan’s Ministry of Health, Labour and Welfare (MHLW).
Emma Ross, VHT Quality Manager, stated: “Building on Volpara’s strong commitment to data security and PHI privacy as witnessed by our ISO27001 certification, we are proud now to also have achieved MDSAP certification. MDSAP is a milestone for regulatory compliance globally as it covers so many countries. The single audit format allows VHT to optimize the resources dedicated to quality and compliance tasks so that the team can continue to develop and deploy the high-quality products our customers have come to expect.”
Volpara will showcase its complete suite of quantitative breast imaging tools (Booth 257) at the American Society for Breast Surgeons Annual Meeting, April 30 – May 5, in Dallas, Texas. Volpara’s suite of products includes Volpara®Enterprise™ software, the only solution available that provides a comprehensive assessment of image quality on every mammogram and tomosynthesis exam, including positioning and compression, which the FDA attributes as the cause of most clinical image deficiencies. The software enables facilities to perform rapid quality control checks that help optimize the productivity and efficiency of imaging resources. As one of the clinical applications within VolparaEnterprise, Volpara®Density™ software provides radiologists with automated, objective volumetric breast density assessments and a breast density category shown to correlate to BI-RADS 4th and 5th Editions. It is CE marked and cleared by the FDA, Health Canada, and the TGA.
About Volpara Solutions
Volpara Health Technologies Limited is a leading provider of breast imaging analytics and analysis products that improve clinical decision-making and the early detection of breast cancer. Every day, Volpara software helps clinicians better understand their patients and administrators better understand their practices. Volpara Solutions is the wholly owned sales and marketing arm of Volpara Health Technologies Limited of New Zealand. Available in most markets where breast cancer screening is commonplace, VolparaDensity provides an objective volumetric measure of breast density from both digital mammography and tomosynthesis data. VolparaEnterprise is a suite of quantitative breast imaging tools for personalized measurements of density, patient-specific x-ray dose, breast compression, breast positioning, and other factors designed to provide critical insight for breast imaging workflow. VolparaLive! provides technologists with a real-time decision support at the point of care to assess image quality. For more information, visit www.volparasolutions.com.
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Chris K. Joseph