Boston, MA (USA) / Leuven (BE) / London (UK)
Gynaia today announced that it has been awarded ISO 13485:2016 and EN ISO 13485:2016 certification (Certificate No. MD 830471) by BSI, one of the world's leading certification bodies.
The certification confirms that Gynaia's Quality Management System (QMS) meets the internationally recognized standard for the design, development, manufacture, distribution, and maintenance of a medical device software for clinical decision support in women’s health.