Considerations for Remanufacturing of Medical Imaging Devices

Abstract

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