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The pdf at the link provided contains a set of FDA reference documents and partial examples used in SoftwareCPR training courses on Validation of Production and Quality System Software and Part 11. This is just a partial set and other examples and checklists are tailored for each course offering.
click here to select the plan that best fits your needs.
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.
