SleepAngel™ Product Compliance
SleepAngel™ products are registered Class I CE marked Medical Devices and in compliance with the Medical Devices Directive 93/42/EEC Gabriel Scientific maintains a Technical File which includes QA procedures, Testing, Risk Assessment, Clinical Research and Trial etc. The Technical File has been audited and Certified by the Competent Authority (the IMB) for implementation of the Directive.
In compliance with requirements placed on Medical Devices, we maintain a technical file which includes clinical and laboratory evidence that a) regular hospital pillows become contaminated and pose risk over time and b) The SleepAngel is a complete barrier to pathogen ingress but crucially it breathes/ventilates through its unique PneumaPure filter device.
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