Device Dossier

Information system, patient record

Device Dossier for Information system, patient record (Information system, patient record, Class IIb, sponsor Mindray Medical). ARTG record, intended…

Intended purpose

A system for electronic registration and storage of patient data, which can be collected from inter-connected medical devices, e.g. patient monitoring devices, but which may also be input manually by clinical staff. Such systems can present this kind of information as graphic display, trends, laboratory results, patient administration data and notes. It is a specially designed data program application (software) which is usually supplied for installation in existing mainframe or decentralized computers or a computer network.

TGA Public Summary