The Medical Imaging and Technology Alliance (MITA) and its parent organization, the National Electrical Manufacturers Association (NEMA) have published a voluntary standard outlining minimum quality management system (QMS) requirements for servicing medical imaging devices. This standard was not approved by the Consensus Group who voted on the Standard after several months of deliberations. ISO and HTMs were concerned among other things that the MITA standard adopted the QSR requirements of the FDA manufacturer regulation but did not adequately address training and calibration of equipment. See the comment in the DOTmed article of IAMERS General Counsel Rob Kerwin expressing this concern. IAMERS is also concerned on the eve of participating in the FDA Collaborative Communities initiative that the unilateral publication and dissemination of a proposed standard (which was defeated) sends a mixed message to the diagnostic imaging community who are being encouraged to work cooperatively with all stakeholders.
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