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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.
ISO 13485 is the internationally recognized quality management standard for the medical device industry.
Achieving this certification demonstrates that Gynaia's processes for product development, risk management, and regulatory compliance meet the rigorous requirements expected of medical device manufacturers operating in international markets.
Our ISO 13485 certification reflects the discipline and rigor embedded in how we build and maintain our software.
It gives partners and clinicians confidence that our clinical decision support tools are developed within a certified medical device quality management system, not just a conventional software development process.
Karen Hensen, Head of Quality & Regulartory Affairs at Gynaia
The certification also recognizes the work of Gynaia's product technology team, who combine disciplined engineering with continuous collaboration with world-leading clinical users and experts from the IOTA Consortium.
Their engineering practices (spanning software design, verification and validation, and post-market maintenance) are the foundation of Gynaia’s QMS.
This certification is an important milestone for Gynaia and for the healthcare organizations that trust our platform.
It establishes a strong foundation as we expand into new clinical applications, combining education, best-practice support, and intelligent software to enhance the entire clinical workflow.
Steven Van Vooren, PhD, CEO at Gynaia
About Gynaia
Gynaia is a women’s health diagnostics company that empowers gynecological professionals with continuous learning, certification, and clinical-grade AI tools to improve care in gynecologic oncology, early pregnancy, obstetrics, fertility, and beyond. By combining explainable AI, regulatory-grade software, and a global expert network, Gynaia enables faster triage, earlier diagnoses, and fewer unnecessary procedures.
For more information, www.gynaia. visit www.gynaia.com / www.gynaia.com/compliance or follow #Gynaia on LinkedIn.