Standards Navigator

Stay up to date and informed of new developments in FDA software regulation, enforcement actions, all the new and emerging standards activities, and gain access to a variety of training aides, document templates, and checklists.  These reports are restricted to our Standards Navigators subscribers.  Items are listed newest to oldest.  If you have trouble finding an item of interest, send email to office@softwarecpr.com.  If you would like to become a Standards Navigator subscriber or our concierge level Standards Navigator PLUS subscriber, go to our Subscribe page.

This tool provides information related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards Navigator keeps you up to date on new standards activity and gives you expert insight into future changes to existing standards.  You will be able to discuss recent draft standards and provide input to SoftwareCPR for the purpose of developing a position or comments on the draft.

Standards Navigator Archive

Item
December 2018 Standards Navigator Report
Standards Navigator Benefits
$62304 Second Edition Questionnaire$
$62304 Second Edition Presentation$
SoftwareCPR Standards Navigator Report for 2018-10
October 2018 Standards Navigator Report
UL 5500 Remote Software Updates Standard
August 2018 Standards Navigator Report
SoftwareCPRStandardsNavigatorReportfor2018-07
SoftwareCPRStandardsNavigatorReportfor2018-05
SoftwareCPRStandardsNavigatorReportfor2018-03
$Standards Landscape March 2018 Update$
SoftwareCPRStandardsNavigatorReportfor2018-01and02
SoftwareCPRStandardsNavigatorReportfor2017-11_12
SoftwareCPRStandardsNavigatorReportfor2017-11
SCPR Standards Landscape Nov 2017 Document
SoftwareCPRStandardsNavigatorReportfor2017-09
SoftwareCPRStandardsNavigatorReportfor2017-08
SoftwareCPRStandardsNavigatorReport2017-07
July 2017 Standards Landscape Status Update
SoftwareCPRStandardsNavigatorReport2017-06
SoftwareCPRStandardsNavigatorReport2017-05
SoftwareCPRStandardsNavigatorReport2017-04
SoftwareCPRStandardsNavigatorReport2017-03
SoftwareCPRStandardsNavigatorReport2017-02
$Jan 2017 SoftwareCPR Standards Landscape$
text
SoftwareCPRStandardsNavigatorReport2016-12
SoftwareCPRStandardsNavigatorReport2016-10
SoftwareCPRStandardsNavigatorReport2016-09
SoftwareCPRStandardsNavigatorReport2016-08
SoftwareCPRStandardsNavigatorReport2016-07
$Draft Health Code of Conduct$
SoftwareCPRStandardsNavigatorReport2016-06
SoftwareCPRStandardsNavigatorReport2016-05
SoftwareCPRStandardsNavigatorReport2016-04
$SCPR 62304 Checklist Revised for Amendment 1$
SoftwareCPRStandardsNavigatorReport2016-03
SoftwareCPRStandardsNavigatorReport2016-02
SoftwareCPRStandardsNavigatorReport2016-01
text
SoftwareCPRStandardsNavigatorReport2015-12
SoftwareCPRStandardsNavigatorReport2015-10
SoftwareCPRStandardsNavigatorReport2015-9
SoftwareCPRStandardsNavigatorReport2015-8
SoftwareCPRStandardsNavigatorReport2015-7
SoftwareCPRStandardsNavigatorReport2015-6
SoftwareCPRStandardsNavigatorReport2015-5
SoftwareCPRStandardsNavigatorReport2015-4
SoftwareCPRStandardsNavigatorReport2015-3
SoftwareCPRStandardsNavigatorReport2015-2
SoftwareCPRStandardsNavigatorReport2015-1
SoftwareCPRStandardsNavigatorReport2014-12
SoftwareCPRStandardsNavigatorReport2014-11
SoftwareCPRStandardsNavigatorReport2014-10
SoftwareCPRStandardsNavigatorReport2014-09
SoftwareCPRStandardsNavigatorReport2014-08
SoftwareCPRStandardsNavigatorReport2014-06
SoftwareCPRStandardsNavigatorReport2014-05
SoftwareCPRStandardsNavigatorReport2014-04
SoftwareCPRStandardsNavigatorReport2014-03
SoftwareCPRStandardsNavigatorReport2014-02
SoftwareCPRStandardsNavigatorReport2014-01
SoftwareCPRStandardsNavigatorReport2013-12
SoftwareCPRStandardsNavigatorReport2013-11
SoftwareCPRStandardsNavigatorReport2013-10
SoftwareCPRStandardsNavigatorReport2013-09
SoftwareCPRStandardsNavigatorReport2013-07
SoftwareCPRStandardsNavigatorReport2013-06
SoftwareCPRStandardsNavigatorReport2013-05
SoftwareCPRStandardsNavigatorReport2013-04
SoftwareCPRStandardsNavigatorReport2013-02
SoftwareCPRStandardsNavigatorReport2013-01
SoftwareCPRStandardsNavigatorReport2012-12
SoftwareCPRStandardsNavigatorReport2012-11
SoftwareCPRStandardsNavigatorReport2012-10
SoftwareCPRStandardsNavigatorReport2012-09
SoftwareCPRStandardsNavigatorReport2012-08
SoftwareCPRStandardsNavigatorReport2012-07
SoftwareCPRStandardsNavigatorReport2012-06
SoftwareCPRStandardsNavigatorReport2012-05
SoftwareCPRStandardsNavigatorReport2012-03
SoftwareCPRStandardsNavigatorReport2012-01
SoftwareCPRStandardsNavigatorReport2011-12
SoftwareCPRStandardsNavigatorReport2011-11
SoftwareCPRStandardsNavigatorReport2011-10
SoftwareCPRStandardsNavigatorReport2011-09
SoftwareCPRStandardsNavigatorReport2011-08
SoftwareCPRStandardsNavigatorReport2011-07
SoftwareCPRStandardsNavigatorReport2011-06
SoftwareCPRStandardsNavigatorReport2011-04
SoftwareCPRStandardsNavigatorReport2011-03
SoftwareCPRStandardsNavigatorReport2011-02
SoftwareCPRStandardsNavigatorReport2011-01
SoftwareCPRStandardsNavigatorReport2010-12
SoftwareCPRStandardsNavigatorReport2010-11