Tag

templates
13
Jun

Software Configuration Management Plan

June 13, 2019,
This template is conceived as a partial example template for a generic small device with embedded real time control. Explanatory comments are included in << comment >>. Other text is example definition that you should replace with your own text. This is not a complete Software Configuration Management Plan, just a training example to guide...
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12
Jun

Software Release Note and Revision History

June 12, 2019,
A SoftwareCPR example for software release note and revision history.  Software Revision Level History Example
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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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20
Dec

QS & Design Tool Validation Training Examples MFG

December 20, 2008
This topic contains selected partial document and procedure training templates as well assorted validation tips for validation of manufacturing and quality system software. 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....
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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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