AAMI Software Related Work Items Update

AAMI Software and IT-related standards working groups include one for interoperability (with 3 standards work items), one for Device Security (with 2 standards work items), one for Wireless, one for SW Defect Classification, and one for AAMI/UL 2800-1 for specification of architecture independent requirements. There is also a separate Health IT Committee with several items under development.

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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