Instructions for Use. The instructions for use is commonly referred to as the physician’s manual, user manual, operator’s manual, prescriber’s manual or reference manual. It contains directions under which the physician or end-user can use a device safely and for its intended purpose. This should include information on indications, contraindications, warnings, precautions, potential adverse effects, alternative therapy and the conditions that should be managed during normal use to maintain the safety and effectiveness of the device.
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Sources: Asean Agreement on Medical Device Directive, Asean Agreement on Medical Device Directive
Instructions for Use. The instructions for use is also commonly referred to as the physician’s physician‘s manual, user manual, operator’s operator‘s manual, prescriber’s prescriber‘s manual or reference manual. It contains directions under which the physician or end-user can use a medical device safely and for its intended purpose. This should include information on indications, contraindications, warnings, precautions, potential adverse effects, alternative therapy and the conditions that should be managed during normal use to maintain the safety and effectiveness of the medical device.
Appears in 1 contract