Search Results for: udi

Emergency assistance

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Any company can suddenly be hit by a complex and high risk case. In such situations it is necessary to get a good understanding of the underlying problem and of the expectations by the authorities and notified body, and also to ensure proper communication with all stakeholders, including the press. Leaning on in person experience … Read more

Justification of product status and risk class

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The justification of the status of a medical device or IVD and their risk class is where you make the first impression Annex VII, Requirements to be met by notified bodies, describes among other things, how a notified body will review applications for certification (Annex VII, section 4.3). These are the first hurdle a company … Read more

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