Consulting services
Overview
XOresearch is a healthcare technology company focused on bringing AI innovation into real-world clinical practice. Its solution, CardioAI™, is designed to support healthcare professionals in the annotation and interpretation of electrocardiograms (ECGs) through artificial intelligence algorithms applied to recordings acquired from legally marketed devices.
To support the next stage of development and market readiness, XOresearch joined TEF-Health and collaborated with Instituto Pedro Nunes (IPN) on a pilot focused on regulatory compliance, quality management improvements, and technical documentation enhancement.
The initiative supported the advancement of CardioAI from TRL 7 to TRL 8, helping the company strengthen the regulatory and operational foundations required to move closer to CE certification and future deployment within European healthcare environments.
Impact
For healthcare AI innovators, regulatory readiness is often one of the most significant barriers separating technological innovation from real-world implementation.
Through TEF-Health, XOresearch was able to address critical compliance and quality management challenges that are essential for bringing AI-enabled medical technologies closer to the European market.
The pilot contributed to strengthening the technical documentation and improving the alignment of CardioAI with MDR requirements and ISO 13485 standards, while also supporting the resolution of nonconformities identified during audits. These activities reinforced the company’s preparedness for CE marking and supported the progression of the solution from TRL 7 to TRL 8, representing an important step toward pre-serial manufacturing readiness and future clinical adoption.
Beyond the technical achievements, the collaboration highlights the role of TEF-Health in supporting healthcare innovators with access to specialised expertise and tailored services capable of accelerating the maturation of trustworthy AI solutions in highly regulated environments.
The Challenge
Although CardioAI had already reached an advanced stage of technological development, important regulatory and compliance-related challenges still needed to be addressed before the solution could progress toward market introduction.
XOresearch faced the complex task of reviewing and updating technical documentation, responding to notified body observations, and resolving nonconformities identified during quality management system audits. At the same time, the company needed to ensure stronger alignment with the European Medical Device Regulation (MDR) and ISO 13485 standards, both of which are fundamental requirements for AI-based medical technologies entering regulated healthcare markets.
Navigating these processes can represent a considerable challenge for healthcare innovators, particularly during the transition from advanced development stages to market-ready solutions.
The Solution
Within the TEF-Health framework, Instituto Pedro Nunes (IPN) provided tailored regulatory consulting and quality management support designed to address the specific needs of CardioAI.
The collaboration focused on reviewing and updating technical documentation, supporting the resolution of audit findings and QMS nonconformities, and providing guidance on MDR compliance and ISO 13485 alignment. In parallel, XOresearch received strategic support related to regulatory planning and EU market entry preparation.
Through this pilot, XOresearch was able to reinforce the compliance, quality management, and operational foundations of CardioAI, strengthening the solution’s overall regulatory preparedness and supporting its progression toward the next phase of development and commercial readiness.
The experience demonstrates how TEF-Health can help healthcare AI innovators bridge the gap between technological advancement and regulatory readiness, enabling promising AI solutions to move closer to safe and trustworthy adoption in clinical environments.
Learn more about the TEF-Health services supporting this pilot:
Regulatory Consulting: Support in QMS Implementation
Regulatory Consulting: Support in the MDs and IVDs CE Marking Process
