Skin adhesive wearables

Manufacturing Wearables

Let R&D Medical custom formulate an adhesive for your wearable device

 

produits_cefaly_2_MG_9444-650x433In order to be classified as a medical device a wearable must be designed for human use and have a diagnostic or therapeutic purpose. The European Medical Device Directive 93/42/EEC defines medical devices as “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”