The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Origin/Publisher:
FDA, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM085371.pdf
Content:
Guideline for industry and FDA Staff for the validation of software regarding medical devices
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