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Medical Devices Standards
Quality management systems, risk management & terminology Standards.
Medical Device Directive (93/42/EEC), a medical device is, "any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software 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
Click here for all relevant Medical Devices Standards.
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