Certified architecture in Picture Archiving and Communication Systems (PACS) and Digital Imaging and Communications in Medicine (DICOM) is not just a technical requirement, but a critical part of providing high-quality healthcare services. Certifications like HL7, ISO 9001, ISO 13485:2016, CE Mark, and GDPR make sure these systems meet strict standards for how different systems work together, quality management, safety, and data protection.

Certification – Easy Data Sharing
These HL7 International standards are crucial for allowing different healthcare systems to share electronic health information. In PACS and DICOM, HL7 certification ensures these systems can work well with other healthcare systems, like Electronic Health Records (EHRs). This ability to work together is essential for providing good patient care, as it means imaging data is easily available to all healthcare providers.

Quality for Reliability

This 9001:2015 certification shows a commitment to quality management. For PACS and DICOM systems, this means the processes used to develop, install, and maintain them are carefully controlled to ensure consistent quality. ISO 9001-certified systems are designed to be reliable, reducing the risk of errors that could impact patient care.

Medical Device Standards

This 13485:2016 certification is specifically for the quality management of medical devices. Since PACS and DICOM systems are considered medical devices, this certification is critical. It ensures these systems are developed and maintained to high safety and performance standards, lowering the chance of system failures that could lead to misdiagnoses or delays in treatment.

Mark – Meeting European Standards

The CE mark shows that a product meets the health, safety, and environmental protection standards set by the European Economic Area (EEA). For PACS and DICOM systems, the CE Mark is legally required to sell in Europe. It confirms these systems are safe for use in healthcare settings, protecting both patients and providers.

GDPR – Protecting Patient Data

The GDPR regulation is an important certification for any system handling personal data in the European Union. PACS and DICOM systems that are GDPR-compliant ensure patient data is processed securely, with strong safeguards against unauthorized access and data breaches. GDPR compliance is not just a legal obligation, but also builds patient trust in digital healthcare solutions.