Continuous process,
not a one-time requirement.
CLARA™ is developed and operated with a strong commitment to regulatory compliance, clinical governance, and responsible deployment within healthcare environments.
Regulatory Awareness & Alignment
Designed with awareness of applicable regulatory frameworks governing digital health technologies. CLARA supports use within established institutional governance structures.
Consideration of European regulatory frameworks, including the Medical Device Regulation (EU MDR), supporting appropriate classification and documentation.
Defined Intended Use
Clearly defining intended use is central to compliance. CLARA is intended as a clinical decision support and research support platform.
Does not provide autonomous diagnosis, treatment recommendations, or emergency medical services. All functionality is developed within this defined scope.
Quality Management & Documentation
Development guided by principles consistent with recognised quality management standards for healthcare software.
Structured documentation of system functionality, version control, change management, and traceability to support internal governance and regulatory review.
Data Protection & Privacy
Designed to align with applicable data protection legislation, including the General Data Protection Regulation (GDPR).
Compliance measures include data minimisation, purpose limitation, role-based access control, and support for data subject rights.
Clinical & Research Governance
Supports auditability and documentation to enable clinical oversight and quality assurance within local governance frameworks.
Research use is subject to appropriate ethical approval, institutional governance, and informed consent processes.
Ongoing Monitoring & Review
Compliance is an ongoing obligation involving periodic reviews and monitoring of use.
Includes feedback from clinical and research users to ensure continued alignment with clinical standards and best practices.
Adapting to your local regulations.
CLARA™ is designed to support deployment across multiple jurisdictions, recognising that regulatory and governance requirements may vary by region.
EU GDPR
Full Alignment
EU MDR
Framework Aware
Local Governance
Flexible Integration
Clinical Audit
Full Traceability