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Delivering Advanced Engineering Solutions |
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This page contains a partial list of guides, related to product reliability, and medical device safety assessment. These guides are stored in PDF format, they can either be viewed or downloaded to your computer.
Please note that these documents have been compiled here for your convenience. To ensure accuracy please refer to each document's source for latest updates, and or notices.
If you like to recommend an update, or additional documents to be listed here, please email your recommendation to webmaster@2aesc.com.
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FDA - CDRH - General Principls of Software Validation
General Principls of Software Validation; Final Guidance for Industry and FDA Staff
| Date: 11 January 2002 |
| Size: 165K |
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FDA - CDRH - Off-The-Shelf Software Use in Medical Devices
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
| Date: 9 September 1999 |
| Size: 92K |
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FDA - CDRH - A Prespective on Medical Device Risk Management
William Midgette
Heart Rhythm Society
Washington, D.C.
| Date: 16 September 2005 |
| Size: 77K |
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