Day

January 6, 2011
06
Jan

$Formal Objection to Harmonization of 14971 by EC$

January 6, 2011,
This content is only available to Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. The link provides the formal objection to the harmonization of ISO 14971 from the European Commission.   EN Deharmonization of Cen-Standards 2010-11
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06
Jan

$Response from ISO TC 210 to the EC objections $

January 6, 2011,
This content is only available to Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. The link provides the response from ISO TC 210 to the EC objections to ISO 14971.  ISO TC210 Comments on deharmonization of EN14971
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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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IEC 62366 Usability Process and Documentation

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