Quality Management for Medical Devices
Neurovalens are an ISO 13485 certified medical device company.
This is an international standard that sets out regulatory requirements for medical device quality management systems.
From the bsigroup.com website:
” ISO 13485 gives regulatory requirements for medical device quality management systems. It provides the basis for ensuring consistent design, development, production, installation, and delivery of products that are safe for their intended purpose. It also harmonizes global requirements and is recognized by regulators in many jurisdictions around the world.”
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Neurovalens is a global health-tech company that creates non-invasive neurostimulation products used to solve some of the world’s greatest health challenges.
Our medical device technology offers unparalleled transdermal activation of the homeostatic nuclei of the brainstem and hypothalamus, allowing for alterations in autonomic function, circadian regulation and Neuro-metabolic influence.
