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What is a medical device?
AS/NZS 3551:2004 (Technical management programs for medical devices) defines a medical device as “Any instrument, apparatus or appliance, including software, whether used alone or in combination, together with any accessories necessary for correct operation, which makes physical or electrical contact with the patient, or transfers energy to or from the patient, or detects such energy transfer to or from the patient, or is intended to diagnose, treat or monitor the patient.
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