The impact of global vigilance reporting requirements on the quality of dialysis products and services
In the past several decades, increased regulation of the drug and device industry has significantly impacted the way manufacturers develop, manufacture, market and monitor medical products. As the distribution of medical products expands globally, so also the need for industry and regulators to understand product safety and performance on a world-wide basis. The resulting depth and specificity of quality system requirements have led to significant demands on both industry and governmental agencies.
KeywordsMedical Device Reporting Requirement Periodic Safety Update Report Global Procedure Durable Medical Equipment
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