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In ISO 13485:2016, requirement 7.5.4 Servicing activities are repair and/or preventative or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications.Īccording to Section 710(c) of FDARA, FDA differentiates the following terms: refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device.
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