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February 25, 2014
Sherman Eagles of SoftwareCPR co-authored AAMI’s recently published article “Reducing Risks and Recalls: Safety Assurance Cases For Medical Devices” in the January/February 2014 issue of BI&T (Biomedical Instrumentation & Technology; a monthly, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation). The full article is posted with permission at the link provided. Any...
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AAMI recently published “Assessing a Hospital’s Medical IT Network Risk Management Practice with 80001-1” in Biomedical Instrumentation & Technology (BI&T). The article reports on an actual hospital network/health IT assessment using 80001-1 as one of the tools for the assessment.
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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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