Densitas wins ISO certification

Densitas has received certification from the International Organization for Standardization (ISO).

The particular ISO standard (13485:2003) details the requirements for quality management systems for designing and manufacturing medical devices. ISO certification lays the groundwork for regulatory submissions, Densitas said.

The company's DM-Density package offers a standardized, reproducible, and automated breast density assessment that integrates with the breast screening workflow, according to the firm.

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