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December 21, 2008
21
Dec

Design Specification Training Template Rev 3$

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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21
Dec

User Interface Design Spec Training Template Rev2$

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 a User Interface Design Specification. UI Design - SoftwareCPR Template-Rev2
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21
Dec

Software Requirements Spec Training Template Rev2$

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 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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21
Dec

FDA Medical Device Reporting webpage

December 21, 2008
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ucm124082.htm
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21
Dec

Device Software SOP & Document Examples

December 21, 2008
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 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

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

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