AI-based medical web app for analysing preterm lab
Innitius is a Spanish MedTech startup dedicated to enhancing diagnostic tools for OB/GYN professionals. Born from a partnership between the University of Granada and the Andalusian Health Service, the company created Cervisense, a diagnostic device aimed at distinguishing between true and false preterm labor. To support this innovation, Innitius required a secure, MDR-compliant AI web application capable of analyzing data from Cervisense, integrating a custom machine learning algorithm, and connecting directly to the device via USB for seamless result retrieval. As a software development firm specializing in regulated medical applications, we assisted Innitius in developing a web application that met all regulatory, technical, and usability standards. The system was built using React, Python, and Django, deployed on AWS, and complied with ISO 13485, IEC 62304, and OWASP guidelines. We also incorporated GDPR-compliant data protection measures and multi-factor authentication based on TOTP for enhanced security. Considering the sensitive nature of preterm labor diagnostics, our emphasis was on reliability, speed, and user-friendliness. The user-friendly design enabled OB/GYN professionals to easily comprehend algorithm-generated risk assessments without unnecessary manual effort. To ensure smooth integration, we worked closely with Innitius’s engineering team, conducting thorough testing using actual hardware. We are continuing to support Innitius as they prepare to enter the US market, assisting with FDA-oriented cybersecurity documentation to ensure they meet regulatory requirements. More details can be found on our website in the "Projects" section.