Called "NEMA/MITA 2 - Requirements for Servicing of Medical Imaging Equipment," the document is a voluntary standard that outlines minimum quality management system requirements for the servicing of medical imaging devices. The standard was developed to apply to any organization that services medical imaging devices, regardless of the size or specific service it provides.
The standard covers processes for training, verification, and validation, and for ensuring that service activities are performed in a way that protects patient safety and the integrity of medical devices, according to MITA. It also includes provisions to ensure that an organization's service activities don't stray into device remanufacturing; the U.S. Food and Drug Administration (FDA) has not yet set guidance clarifying the distinction between service and remanufacturing.
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