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SALMD Framework in Medical Devices

SALMD Framework in Medical Devices

Abstract

The advent of Laboratory Information Management Systems (LIMS) in the Medical Device industry triggers HCL to come up with the SALMD framework enabling a conceptual approach towards Health Care & Service space. LIMS can be very well used in the medical device industry in manufacturing as well as validating medical devices. The areas include Corrective and Preventive Action (CAPA), Quality Assurance, Labeling and Packaging Control etc. Both for Reprocessing Medical Devices and Single Usage medical Devices LIMS support would prove beneficial.

Excerpts from the Paper
Using  SALMD  framework  LIMS  plays  its  role  in  validating  a medical device, we therefore plan how to design the specification for the same and also plan the deciding factors of the specification plan. The next step towards the SALMD approach is to implement the  plan  and  document  the  procedures  and  observations.  The specification  could  then  be  executed  to  achieve  at  the  results. Corrective actions could be implemented if required and repeat the PDCA cycle or else if the results are expected and the specification passes, then do nothing.

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