EU MDR IIa – verified for clinical use
Carebot is certified under the EU Medical Device Regulation (MDR) as a Class IIa medical device. This means that it is clinically evaluated, safe, and legally approved for use in hospitals and radiodiagnostic centers throughout the EU.
What does this mean in practice?
Our modules (AI CXR, AI BONES, AI mammography, AI Head CT, and AI Lungs CT) are each CE-marked and compliant with applicable regulatory requirements.
Clinical evidence is registered in the European EUDAMED database.
The algorithms undergo regular audits and are continuously updated based on new data.
Performance results and metrics are supported by peer-reviewed studies and have been presented at international congresses, including ECR and ESMO.
CE mark – standard for the European market
The CE mark confirms that Carebot complies with technical and safety requirements under European legislation. It is an integral part of MDR certification and a key prerequisite for deployment in hospitals across the European Union.
What does this mean in practice?
CE marking is indicated for each module in both the documentation and the user interface.
It is granted only after full compliance with all requirements defined by harmonized standards.
The system has been assessed by the notified body NB 1023.
CE marking provides legal certainty for public procurement and cross-border deployment.
ISO/IEC 27001 – security standard for data handling
Carebot is developed and operated in accordance with the international ISO/IEC 27001 standard for information security management. This standard defines how data are protected against misuse, breaches, and loss.
What does this mean in practice?
All data are encrypted both in transit and at rest.
System access is protected by two-factor authentication.
Regular risk assessments and security reviews are performed.
IT processes are aligned with hospital IT requirements and audit standards.
ISO 13485 - quality management system for medical devices
ISO 13485 is an international standard that defines requirements for a quality management system specific to medical devices. It ensures that organizations consistently design, manufacture, and deliver medical devices that are safe, effective, and compliant with regulatory requirements.
What does this mean in practice?
Quality management system covers the entire medical device lifecycle.
Product safety and performance risks are systematically managed.
Design, production, and quality processes are documented and controlled.
Compliance with medical device regulations is ensured.
GDPR compliance – protection of patient data
Carebot fully complies with the European General Data Protection Regulation (GDPR). Patient data are processed securely, minimally, and in line with the requirements of healthcare providers.
What does this mean in practice?
Images and metadata are pseudonymized before AI analysis.
Data never leave the hospital without consent and controlled access.
The system can be deployed on-premise or in a secure European cloud.
Data processing rules are clearly defined in both contractual documentation and technical specifications.
