Day

November 23, 2020
23
Nov

ISO 14971 Updated in 2019 Release

November 23, 2020,
ISO 14971 was updated and released in 2019.  We previously discussed the internal debate regarding ISO 14917 in this post ISO 14971 versus the EU Commission. There are several items to consider with the new update: Section 10.1 – “The manufacturer shall establish, document and maintain a system to actively collect and review information relevant to...
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ISO 14971 SaMD Risk Management

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IEC 62366 Usability Process and Documentation

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