Part 11 SoftwareCPR Explanation and Commentary$

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The attached document is a SoftwareCPR training aid with commentary and explanation of 21 CFR Part 11 Electronic Records; Electronic Signatures by SoftwareCPR.  Note the date of this document as this is an evolving area.

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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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