19:31 Aug 17, 2017 |
German to English translations [PRO] Medical - Medical: Instruments / FDA Medical Device Reporting | |||||||
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| Selected response from: David Hollywood Local time: 05:27 | ||||||
Grading comment
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Summary of answers provided | ||||
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3 +2 | presumption/assumption |
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3 | suspected risks |
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3 | reasonable suggestion |
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Discussion entries: 13 | |
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suspected risks Explanation: Suspected risks associated with medical devices? I don't think you would use an isolated noun or verb-turned-noun in the first place. That's often done in German but doesn't work really well in English. -------------------------------------------------- Note added at 1 hr (2017-08-17 20:56:03 GMT) -------------------------------------------------- "An employee of the organization has received information that gives rise to the suspicion that an undesired event has occurred that needs to be reported." |
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presumption/assumption Explanation: Das Medizinprodukt könnte zu einer potentiell tödlichen oder schwerwiegenden Verletzung führen. The medical product/device could lead to a potentially fatal or serious injury. -------------------------------------------------- Note added at 1 hr (2017-08-17 21:16:19 GMT) -------------------------------------------------- An MDR guidance for manufacturers issued in 1997 stated that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established. |
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Grading comment
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21 hrs confidence:
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