Skip to Content

CardioAI Pilot for ECG Analysis and CE Certification

Advancing AI-Based Cardiac Diagnostics
SME / Company XOresearch
Service Provider Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)
Disease / Clinical Domain Cardiology
Product / Solution CardioAI™
Validation Needs Regulatory Consulting

About XOresearch

XOresearch is a company focused on providing AI technology to real-life products for healthcare. The company develops CardioAI, which uses AI to automatically annotate and interpret electrocardiograms captured and recorded by any legally marketed source. This software medical device enables unattended cardiac monitoring with a seamless EHR interface

The Challenge

  • Technical documentation review and updates
  • Resolution of QMS nonconformities identified during audits
  • Support for MDR compliance and ISO 13485 certification
  • Guidance on regulatory strategy for EU market entry

The Story

CardioAI™ is designed to assist healthcare professionals in ECG interpretation using AI algorithms. The pilot aimed to overcome the regulatory barrier preventing market introduction. Activities included reviewing technical documentation, addressing NB deficiency reports, and resolving QMS nonconformities through corrective actions and updates aligned with ISO 13485 standards.

The pilot successfully advanced CardioAI from TRL 7 to TRL 8, achieving pre-serial manufacturing readiness and compliance with MDR requirements. This milestone positions the company for CE certification and broader adoption in clinical environments.

Key Outcomes:
- Updated technical documentation and QMS compliance
- Resolution of audit findings and nonconformities
- Preparedness for CE marking and EU market entry

Services Used

Regulatory Consulting: Support in the MDs and IVDs CE Marking Process
Consulting Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

With special focus on active devices, IPN supports manufacturers, distributors, and importers of MDs and IVDs, in the CE marking process taking into account the applicable requirements of Regulation (EU) 2017/745 (Medical Device Regulation - MDR) or Regulation (EU) 2017/746 (In Vitro diagnostic Medical Device Regulation – IVDR), as applicable. In this context, IPN supports the implementation and review of the Quality Management System (QMS), together with the elaboration or revision of the Technical Documentation (TD) of the device (under Annex II and Annex III of MDR or IVDR). IPN also support the company, depending on the device class, with the submission of the certification request to a notified body.

→ View Details
Regulatory Consulting: Support in QMS implementation
Consulting Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

The MDR and IVDR states in Article 10 (9), the requirements for the Manufacturer’s QMS. Despite not being specified, ISO 13485 is the most suitable quality management systems standard for medical devices companies. In the US, manufacturers must comply with the FDA’s Quality System Regulation (21 CFR Part 820), which outlines similar requirements for design, production, and process controls. The IPN helps medical device and IVD companies implement their QMS in compliance with the applicable regulatory framework. So, in order to meet the requirements and also operators’ specific needs, IPN team work closely with each section or department representatives.

→ View Details

Healthcare Problems Addressed

  • • Manual ECG interpretation
Health Force AI Pilot for Hospital Administrative Automation
Validating AI Agents for Streamlined Hospital Administration at ULS Coimbra