Densitas, a Halifax startup developing software that enhances mammography, his issued the following press release:
DENSITAS RECEIVES ISO 13485:2003 CERTIFICATION
HALIFAX, Nova Scotia – May 28, 2015 – Densitas Inc. announced today 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 startup company that develops software for use in the digital mammography enterprise.
This milestone achievement underscores the company’s commitment to developing quality software products that meet clinical, administrative and IT needs of radiology clinics and health care providers, with the goal of improving appropriateness of care.
ISO certification is also an added assurance for customers in international markets that Densitas products will meet national standards throughout their lifespan.
“In our industry, ISO certification is a given,” said Mohamed Abdolell, CEO of Densitas. “It also sends a clear message that our products are developed to rigorous standards and allows our sales team to pursue business development opportunities at a global level.”
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 breast density assessment that integrates with the breast screening workflow. Regulatory activities are under way in the EU, Canada and the US.
Densitas Inc. is an early stage software medical device company, developing digital mammography products designed to meet the clinical, administrative and IT needs of radiology clinics and health care providers, with the goal of improving appropriateness of care. The company’s data-‐driven solutions distill valuable information from the vast quantities of data generated in digital mammography. Densitas’ product pipeline will continue to solve real challenges in the delivery of healthcare.