Bringing a device in or swapping one out follows a system. Devices are on the ARTG, or, if made in-house, validated to ISO 15189 and compliant with NPAAC and regulatory requirements (class 4 in-house IVDs generally need ARTG inclusion; class 1 to 3 need annual notification to the TGA) and in line with industry good practice; consultation and change management accompany the decision; suitability for the patients served is assessed; the device is tested against the specifications the manufacturer claims and shown to meet them; recognised reference standards or methods validate its performance; calibration, quality control and quality assurance are in place before go-live; ageing or under-performing devices are tracked and managed as risks; and performance is watched continuously and reviewed periodically, with revalidation or re-verification after a significant change, new evidence or an identified risk.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.