Comprehensive equipment list to pass the iso audit the company must demonstrate that it has a comprehensive equipment list with controls in place for additions subtractions and custodianship of equipment.
Calibration of medical equipment pdf.
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Maintain the appropriate medical equipment maintenance records iaw tb 38 750 2 maintenance management procedures for medical equipment or approved automated equipment management system.
Accredited calibration lab the calibration laboratory must be iso 9001 2008 accredited or be the original equipment manufacturer.
Iso 9001 accredited and quality assured biomedical technicians.
Calibration of medical devices and manufacturing equipment needs to be performed on a routine basis by trained and certified professionals.
We can help you best manage your medical equipment in line with as 3551.
We have decades of experience managing calibration programs in.
If errors are noticed adjustments and repairs need to be made followed by re calibration to verify the accuracy of calibrated equipment.
17 thto 19 dec 2014.
Need medical equipment test and tag medical equipment calibration or medical equipment testing or servicing.
A top priority for medical device manufacturers is the health and safety of patients and the accuracy and precision of the instruments used in production is of the utmost importance.
The eu medical device directives the medical devices directive 93 42 eec oj l169.
Medical equipment repairers.
From bandages tongue depressors thermometers to contact lenses stethoscopes splints heart valves and imaging equipment the in vitro diagnostic medical devices directive ivdd 98 79 ec oj l331.
Maintain organization s medical equipment in a fully mission capable status iaw ar 220 1 unit status reporting and ar 700 138 equipment readiness.
Medical equipment management a proactive approach.
Medical equipment calibration calibration and asset management for medical device manufacturers.