Ch 5 Managing Medical Devices within a Regulatory Framework

What is it about?

The introduction of emerging materials, novel technology and the agency strain to keep pace to maintain regulatory guidance can be mitigated by a litany of professionals piecing together solutions towards the progressive formation of a healthcare system. The path to a healthcare system is one in which knowledge, information, application, and implementation involving multiple stakeholders throughout the medical device produce life cycle must continue to find points of intersection. To that end, we apply recommendations to review the impact of biocompatibility, risk management and sterility from the United States Food and Drug Administration and Association for the Advancement of Medical Instrumentation to clinical engineering in order to help close the gap.

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Why is it important?

Patient safety.