Clinatec / CEA
Transcranial photobiomodulation medical device
Technical approach
From functional prototype to certified production — a complete medical device development process.
Architecture & initial assessment
Full system structuring.
- + Existing prototype analysis
- + Electronics, mechanical and textile architecture definition
- + Medical and regulatory constraint integration
- + Precise light dose control management
Design & validation
Developing a reliable, reproducible device.
- + Embedded electronics integration
- + Functional textile integration
- + Functional testing and validation
- + Optimization for clinical use
Certification & production
Transition to a certified medical device.
- + Class IIa medical device certification documentation
- + Product traceability system setup
- + Small series production and final testing
Results
The device is now certified as a Class IIa medical device and produced in small series with full traceability.
It is currently used in clinical trials, enabling the evaluation of photobiomodulation across various neurological conditions.
Status: certified device — in clinical trial
Related expertise
End-to-end medical device development
AQ-Tech combines product engineering, embedded electronics and industrialization to turn prototypes into certified medical devices.
Smart Textile
Sensor, conductor and connected module integration into garments and wearable devices.
Mechanical engineering
Product integration and design adapted to medical regulatory constraints.
