منابع مشابه
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By the spring of 2005, the European Commission hopes to present the first draft of the revisions to the Medical Device Directive to the European Council and Parliament. However, these revisions represent only part of the changing European regulatory scenario. This article discusses a tangible shift in European medical device regulatory policy and some actions that companies can take to understa...
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There are three main stakeholders in medical device regulation: people in industry, regulators and practitioners. A medical device report is filed after a device-related adverse event occurs. Studies show that while most medical device reports begin with practitioner observations, people in industry file 97% of reports and practitioners file 3% of reports. The objectives of this article are to ...
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ژورنال
عنوان ژورنال: Biomedical Journal of Scientific & Technical Research
سال: 2018
ISSN: 2574-1241
DOI: 10.26717/bjstr.2018.04.0001008