Grounded in the IOTA consortium legacy, access to structured clinical data and trusted, leading experts worldwide.
MedDev Partnership Programme
Bring your own clinical decision-support solution to market, or integrate certified models into your software or ultrasound systems.
Why work with Gynaia
Regulatory excellence.
ISO, QMS and SaMD expertise.
Certified under ISO 13485 with full SaMD development and compliance capabilities.
Technical depth.
Proven software, AI, and RWD expertise
Software, data science and AI experts experienced in building and validating clinical-grade tools.
Clinical credibility.
Built on authorotative IOTA consortium foundations.
MedDev partnership programme
Gynaia helps turn clinically validated ideas into regulated, deployable medical devices in gynecology, women’s health, fertility, obstetrics, and early pregnancy.
From research to clinic
Bridging the gap from research to clinical use
Many published models never reach patients due to the cost, time, expertise, and regulatory complexity required for market entry.
We bridge that gap — combining technical, clinical, and regulatory excellence to bring compliant, usable, and scalable decision-support tools to real-world practice.
Bridge the gap to the clinic
For innovators and clinical researchers
If you have developed a diagnostic or predictive model from academic or clinical research, Gynaia provides the path to market.
We help transform promising research into robust, auditable, and supported clinical tools that meet MDR and UKCA standards.
Our experienced regulatory, software, and AI teams cover every step: ISO 13485-compliant QMS, SaMD classification and registration, validation studies, data capture through our Clinical Data Miner platform, AI and software engineering, and post-market support.
For OEM partners
For OEM partners
Ultrasound and clinical software vendors can integrate medical-device-grade decision-support tools directly into their products.
Through Gynaia’s certified models, such as the ADNEX app (our first SaMD implementation), partners can enhance diagnostic capabilities and compliance while reducing regulatory overhead.
We offer flexible collaboration models, across co-development, clinical validation projects, on-device integration, and co-marketing.