The CE class-IIA medical device certification (ISO-13485 Medical Device Quality Management by BSI) confirms that the Flow device is licensed for medical use and compliant with the strict European laws for medical devices.
The CE certification ensures that:
1) Flow is based on scientific evidence
2) the treatment reduces depressive symptoms
3) the headset is safe to use
As part of the certification process, third-party experts on brain stimulation have reviewed the scientific evidence proving that the technology used in the Flow headset is both safe and effective. The approval process took two-years and was carried out under the Medical Device Directive by the BSI.
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