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INDEPENDENT SERVICERS WOULD BE REQUIRED TO DEVELOP SERVICE AND INSTALLATION PROCESSES TO ENSURE DEVICE CONFORMANCE TO SPECS UNDER HIMA/NEMA PROPOSAL

This article was originally published in The Gray Sheet

Executive Summary

Independent service and repair organizations would have to develop their own service and installation processes to ensure that a device continues to conform to its original specifications under a draft ISRO quality system regulation developed by the Health Industry Manufacturers Association and the National Electrical Manufacturers Association. Under the draft reg, service firms would have to develop and document their own processes when they have not "contractually obtained" procedures established by the device manufacturer.
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