Building a Regulated SaMD Platform for Preterm Birth Risk Assessment – Alpha Delivered in 12 Months to a Certifiable Standard

A validated blood test needed regulated digital products – built to a standard that could support future regulatory review and market authorization.

Our client operates in women’s health diagnostics in the US, focused on improving the health of pregnant women and newborns. Their core product is a clinically validated blood test that assesses the risk of spontaneous preterm birth – one of the leading causes of neonatal complications worldwide.

The blood test worked. What it lacked was a digital layer to put results in patients’ and physicians’ hands. The client wanted to design, test, and build digital products that would improve communication with patients and ease interactions between patients and physicians.

But this wasn’t ordinary app development. Because the software would interpret clinical data and inform medical decisions, it had to be regulated as a Software as a Medical Device (SaMD). That raised the bar dramatically. The development partner had to own the entire software development lifecycle and maintain traceability to a certifiable standard – so the finished product could be validated and cleared for clinical use.

The client needed a partner who understood both modern product engineering and the discipline of regulated medical software – IEC 62304, ISO 14971, FDA QSR, HIPAA, and the FDA 510(k) pathway. They chose Yalantis.

A four-module regulated digital-health platform connecting patients, physicians, and clinical data

Yalantis designed and built a regulated platform that helps pregnant individuals understand their pregnancy risks through blood tests and surveys – providing contextualized risk information using the client’s validated clinical models and reference data – and take action to manage those risks. The platform consists of four integrated modules:

What it takes to build medical-grade software

Delivering a Software as a Medical Device means engineering discipline at every layer.

Yalantis owned all of it:

• SDLC & traceability. A disciplined lifecycle with full traceability and documentation for compliance – every requirement traceable to its design, code, and validation.
• IT security & data protection. Encryption in transit and at rest, two-factor authentication, data and account deletion, and more – meeting HIPAA and medical data protection requirements.
• Infrastructure & DevOps. AWS serverless environments provisioned as Infrastructure-as-Code, with post-release Site Reliability Engineering (SRE) support.
• Software design & build. React Native patient app, React physician web app, and Node.js/Nest.js backend – delivered across Alpha and Beta gates.