Day

October 25, 2016
A final draft (FDIS) of “IEC 82304-1: Health software – Part 1: General requirements for product safety” has been approved. The standard will be published after final editing. This is expected around the end of the year (2016). The primary focus of this standard is on requirements for the developers of the software product. It...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

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ISO 14971 SaMD Risk Management

Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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