We provide timely, accurate and affordable accreditation testing for an extensive range of biomedical devices.
Peformance Validation
Verify as recommended by the medical equipment manufacturer;
Verification of procedures undertaken by the medical equipment user;
Level and reliability of in-built self-testing, or self-verification within the medical equipment;
Cross verification within a single test regime, e.g. rate meter checked when alarm function checked;
Stability/maturity of technology;
Operational environment in which the medical equipment is used;
Operational experience with the medical equipment, or similar types of devices, such as failure rate
Requirements of the preventive maintenance identified at the time of medical equipment acceptance.
Physical Inspection (AS3551:2012)
Check equipment is free from external damage.
Where internal damage to the medical device is suspected, a check that internal assemblies are secure, such as relays, connectors and printed circuit boards.
Check for any damage or defect in the accessories, such as connectors, plugs, appliance
coupler and sockets.
Check that cord grips and protective casing, are effective.
Check expiry date on critical components and accessories, such as batteries, patient electrodes.
Calibration & Safety Testing
Testing of all patient inputs and outputs functions by applying calibrated patient simulated signals to ensure equipment is operating within manufacturers calibrated specifications.
