Cefaly is a patented system and bears the CE medical mark.
It has been designed and developed in accordance with the strictest quality standards, complying with directive 93/42/EEC pertaining to medical devices and with all associated international IEC standards.
Maximum safety
Cefaly uses TENS technology, which has been known about in medical circles for over 40 years and is used in pain treatment centres.
This technology is renowned for its safety and absence of side-effects.
Cefaly was designed and developed in line with a strict risk analysis compliant with international standard ISO 14971 applicable to medical equipment.
This analysis has eliminated all possible short-term and long-term dangers.
The only precautions and notable side-effects are as follows:
- Do not use Cefaly whilst driving
- Redness of the skin in the area around the electrode may persist for a few minutes after the session has ended.
Clinical tests
Several tests and studies have confirmed Cefaly’s complete safety.
It works by using natural physiological mechanisms.
Scientific literature, as well as repeated clinical testing, have demonstrated that Cefaly® is completely harmless.
All the substances and materials used are bio-compatible and have been subjected to skin testing.
No clinical studies carried out with Cefaly have revealed any evidence of side effects or problems.
Several million treatments with Cefaly have been monitored and no problems or side effects were reported.
CE & ISO Medical
CE Medical mark
Cefaly bears the CE Medical mark. Independent official bodies have checked that it complies strictly with the European directive applicable to medical devices, namely 93/42 EEC.
As part of its ISO Medical certification process, STX-Med has implemented a monitoring system. This system reports that tens of millions of Cefaly devices have been in regular use for several years and not a single incident has been reported.
ISO Medical certification
STX-Med, the company that designed and produces Cefaly, is ISO-certified.
The design, development and production processes comply with the strictest quality standards.
ISO Medical 13485: 2003 (quality system specific to medical material)
ISO Medical 13485: 2003 under CMDCAS (Canada)
ISO 9001: 2008 (complete quality system)
