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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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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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