IEC 80002-1 and 80001-1 reconfirmed to 2016

IEC 80002-1 “Guidance on the application of ISO 14971 to medical device software” has been reconfirmed with a new stability date of 2016. This means that the document will not change before 2016. The next review to determine if the technical report should be revised will occur in 2015.

IEC 80001-1 “Application of risk management for IT-networks incorporating medical devices” has been reconfirmed for one year with a new stability date of 2016. Revision of this standard will begin in 2014.

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

Or just email training@softwarecpr.com for more info.

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