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December 21, 2008
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf is a training aide and should not be used blindly to fill in the blanks. It is a partial example of Software Design Specification tailored from an IEEE standard. Design Spec - SoftwareCPR Template-Rev3
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf is a training aide and should not be used blindly to fill in the blanks. It is a partial example of a User Interface Design Specification. UI Design - SoftwareCPR Template-Rev2
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf is a SoftwareCPR training aide and should not be used blindly to fill in the blanks. It is a partial example for a software requirements specification (SRS) for a small surgical device. SRS-template-embeddev-SoftwareCPRtrainingdocRev2 . . ....
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http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ucm124082.htm
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This topic contains selected partial document and procedure training templates as well as assorted validation tips. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access. Other training aides may be provided to...
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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

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

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