Day

October 17, 2017
I don’t even really like to use the word retrospective
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The link provided is to the full text of the current Bill S.1656 in the US Congress titled “Medical Device Cybersecurity Act of 2017.” Note that bills may not pass into legislation or may be heavily modified prior to becoming law. S.1656
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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