Strategic planning for U.S. premarket approval submissions.
نویسنده
چکیده
The United States premarket approval (PMA) process is costly and time-consuming and differs in important ways from the CE-marking process. This article discusses the importance of strategic planning for submission of a PMA and the issues that should be considered, which can lead to a reduction in the time and cost involved.
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ورودعنوان ژورنال:
- Medical device technology
دوره 17 7 شماره
صفحات -
تاریخ انتشار 2006