Day

November 25, 2008
IEC/CD2 80001, Application of risk management for IT-networks incorporating medical devices was released for balloting on 11/25/2008 by AAMI. This standard applies to Medical Device manufacturers as well as healthcare IT organizations. The deadline for comments is Jan 15, 2009. An article about this standard by SoftwareCPR partner Sherman Eagles is posted on this website.
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SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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