Avoiding surprises when implementing a single quality system.
نویسنده
چکیده
European medical device manufacturers are sometimes surprised to learn that operating ISO 13485 alone is not sufficient to meet United States (US) quality system requirements. This article discusses important considerations for meeting US and European requirements when operating under a single quality system.
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عنوان ژورنال:
- Medical device technology
دوره 20 2 شماره
صفحات -
تاریخ انتشار 2009