Compliance of Medical Software
Compliance, Certifications & Security
At the core of our Medical Information Systems lies an unyielding commitment to security, quality, and regulatory compliance. We don’t just meet industry benchmarks—we set them. By aligning our platform with the most stringent global data protection frameworks and medical software standards, we guarantee absolute data integrity, ironclad cybersecurity, and seamless interoperability for clinics, laboratories, and hospitals worldwide.
- GDPR Compliant (General Data Protection Regulation)
Full alignment with the European Regulation (EU) 2016/679. We ensure the highest level of privacy, encryption, and legally compliant management for sensitive medical records and patient personal data.
- ISO 27001 Certified (Information Security Management)
Implementation of the gold standard for Information Security. We guarantee robust data integrity, advanced threat mitigation, and cyber-attack prevention across both our Cloud and On-Premise infrastructures.
- ISO 13485 Certified (Quality Management for Medical Devices)
Adherence to the strict international standard governing the design, development, and support of Software as a Medical Device (SaMD).
- ISO 9001:2015 Certified (Quality Management Systems)
Certification for the continuous optimization of our internal operations, from the very first line of source code to our 24/7 specialized technical support.
- ISO 27779 Certified (Cloud Security & Privacy)
Specialized international standards confirming advanced security controls and the ultimate protection of Personally Identifiable Information (PII) specifically within Cloud Computing environments.
- ESYD Accreditation (National Accreditation System)
Engineered to align perfectly with national frameworks, (ESYD or CAP / UCAS/ DAkkS / COFRAC / ACCREDIA) our platform provides the mandatory structure, of result forms reporting, and internal audit logs required by ESYD.
- CAP Accreditation (College of American Pathologists):
For advanced pathology and clinical laboratories aiming for the global gold standard, our software follows CAP checklists instructions through automated peer-review workflows, specimen tracking, and rigorous proficiency testing data management.
- ASTM & Analyzer Communication Protocols
Full integration with international instruments data exchange protocols. (interfacing). This allows our systems to communicate flawlessly with any medical analyzer or any other diagnostic device globally.
- HL7/FHIR & DICOM Compliant (Global Medical Interoperability)
Full integration with international medical data exchange protocols. This allows our systems to communicate flawlessly and natively with any Hospital Information System (HIS), PACS, or medical information subsystem.
- CE Marked & MDR / IVDR Compliant
Our software carries the official European CE marking, fulfilling all strict safety, health, and environmental protection requirements for clinical software and in vitro diagnostic devices.
Compliance of Medical Software
Implementing our software dramatically simplifies and accelerates your journey toward achieving prestigious global quality marks. By embedding strict compliance and proper reporting into your daily operations, our platform serves as a continuous preparation tool for key accreditations:
- Joint Commission International (JCI):
Our system automates patient safety goals, ensures strict clinical protocol adherence, and provides flawless traceability of medical actions, making your hospital or clinic fully compliant with JCI’s rigorous quality metrics.
- ISO 15189 (Medical Laboratories):
For diagnostic and clinical laboratories, our platform enforces total quality control (QC), automates analyzer calibration tracking, secures pre- and post-analytical phases, and provides the ironclad data integrity mandatory for ISO 15189 certification.
- TEMOS International:
Designed for global healthcare mobility, our software supports international patient management, multi-language documentation, and clinical outcome tracking, enabling healthcare providers to seamlessly meet TEMOS excellence standards.
