firmware and other means for software-based control of medical devices; stand-alone software applications; software intended to be operated on general-purpose computing platforms; dedicated ...
The draft is a near total overhaul of the document finalized by FDA in 2005, with only short sections on topics such as software verification and the history of software revisions surviving unchanged.
Multinationals face rising TP scrutiny as global rules diverge. As Daniel Moalusi argues, strong, consistent documentation is ...
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