Densitas Breast Density Software Receives ISO Certification

Densitas Breast Density Software Receives ISO Certification
Certification recognizes quality design and manufacture of breast density assessment software
June 10, 2015
June 10, 2015 — Densitas Inc. announced it has received 13485:2003 certification from the
International Standards Organization (ISO). This ISO standard specifies the requirements for
comprehensive quality management systems for the design and manufacture of medical devices.
Densitas is an early stage start-up company that develops software for use in the digital mammography
ISO certification lays the groundwork for submissions to regulatory bodies to begin selling products in
a variety of countries. Densitas’ flagship product is DM-Density. It provides a standardized, reliably
reproducible and fully automated fibroglandular breast density assessment that integrates with the
breast screening workflow. Regulatory activities are underway in the EU, Canada and the U.S.
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