Devices are ubiquitous in the delivery of modern health care. Diagnostics
and therapeutics rely on a bewildering, constantly changing array of devices
used to monitor and treat patients. Trends in device evolution include increasing
complexity and autonomy of operation, device-device interactions, miniaturization,
and integration with information technology. Managing risk associated with
devices has thus long been a central concern of policy makers, manufacturers,
and those providing health care.
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