Day

October 23, 2004
While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach. In Canada the blood establishment is regulated. Computer systems used in donor establishments are not considered medical devices and are regulated through the establishment licensing process. Unlike with the...
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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

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