NEMA - National Electrical Manufacturers Association
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NEMA MITA RMD P1-2019
Scope
Introduction Medical devices are subject to a number of post-sale aftermarket activities@ including servicing@ upgrading@ updating@ refurbishing@ and remanufacturing. These activities@ when performed correctly and in conformance with applicable Federal regulations@ can ensure safe and effective performance over the lifecycle of the device. Unfortunately@ these activities are not always performed correctly with applicable oversight@ creating potential patient safety and device performance issues.
NEMA MITA RMD P1-2019 history
2019NEMA MITA RMD P1-2019 Considerations for Remanufacturing of Medical Imaging Devices