Reliability,
by design.
Medical device regulations, data protection laws, and AI ethics frameworks — we design compliance in from the start, not after.
Compliance roadmap.
Medical Device Software
Lifecycle processes. NeuroFlow software development processes are structured in accordance with this standard.
Quality Management System
Quality management system requirements for medical device manufacturers. Documentation and traceability.
EU Medical Device Regulation
CE marking roadmap for European market access. Application planned as Class IIa medical device.
EU AI Act
Classification as high-risk AI system. Transparency, explainability, and human oversight requirements.
Data Protection
Protection of personal health data. Thanks to edge computing architecture, raw EEG data never leaves the device.
privacy by design →Electrical Safety
Basic safety and performance requirements for medical electrical devices.
Intellectual property protection.
Edge Computing BCI System
Real-time EEG signal processing and classification method on edge device. Cloud-independent operating architecture.
Adaptive Learning Algorithm
Machine learning approach providing user-specific calibration and accuracy improvement over time.
Multi-Language BCI Communication System
Multi-language text generation method in brain-computer interface with Turkish morphological analysis integration.
CE Certification Roadmap
CE marking process as Class IIa medical device planned with Q3-Q4 2025 target.
We develop technology within ethical boundaries.
Informed Consent
All users and test participants are clearly informed about data collection processes.
Data Minimization
Only the minimum necessary data is collected. Raw EEG signals never leave the device, only processed results are stored.
Explainable AI
Explainability metrics are used to ensure model decisions are transparent. Users can understand how the system works.
Human Oversight
The system always operates under expert human supervision in clinical contexts. Autonomous medical decision-making is not targeted.
Learn about compliance details.
Contact us for detailed information about our regulatory processes and certification roadmap.
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