![]() The regulation is designed and intended to function with other management systems around the world, and by doing so, work more efficiently and transparently with each other. ![]() ISO 13485 is the international standard for quality management systems (QMS) that establish requirements for regulatory purposes for the medical device sector. Recent news that the US Food and Drug Administration (FDA) will use ISO 13485 as the basis for its quality system legislation for medical devices was well received by those in the industry, perhaps none more than the ISO (International Organization for Standardization) itself.
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