Yes, iQ-ROUTER supports GDPR (DSGVO) compliance requirements for handling patient data and medical imaging information within healthcare organizations. The system includes features for secure data routing, controlled access, anonymization, and protected handling of sensitive DICOM information in compliance with European privacy regulations. GDPR-compliant workflows help healthcare providers securely manage medical imaging data across clinical and enterprise imaging environments.

Yes, IMAGE Information Systems Europe GmbH operates a certified quality management system according to EN ISO 13485. This certification demonstrates compliance with internationally recognized quality standards for medical device manufacturers and healthcare software development. ISO certification supports high-quality product development, regulatory compliance, and healthcare software reliability.

Yes, iQ-ROUTER is part of the iQ-SYSTEM PACS platform and is certified according to the European Medical Device Regulation (MDR). The software complies with European regulatory requirements for medical imaging, healthcare IT systems, and diagnostic imaging workflows. CE certification supports the use of iQ-ROUTER within European healthcare organizations and clinical environments.

Yes, iQ-ROUTER is part of the iQ-SYSTEM PACS platform, which is FDA cleared for medical imaging and diagnostic use. The system is designed to support professional radiology workflows, medical image management, and healthcare IT environments. FDA clearance confirms compliance with applicable regulatory requirements for medical imaging software solutions.