EU Battery Regulation: What medical device manufacturers need to know
The EU plans to replace the existing Directive 2006/66/EC with the new EU Regulation on batteries and waste batteries (“Battery Regulation”). This article clarifies,
DetailsOpen-source software as a medical device?
University institutions in particular regularly publish medical software as open source. This raises doubts as to whether this open-source software counts as a medical device and what regulatory and (product) liability risks are involved. This article provides a quick overview.
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