Day

February 12, 2001
12
Feb

FDA CDRH Inspection Guide Lists FDA SW Contacts

February 12, 2001
The final Device Center Inspection Compliance Policy Guide (provided at the link above and in the Library on this site) Part VI, Page 11, lists the following as points of contact related to software: “i. Questions regarding compliance of product software, stand alone software, process equipment software or the Year: 2000 Problem: Stewart Crumpler Office...
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12
Feb

SoftwareCPR.com February 2001 Newsletter

February 12, 2001
/docs/SCPRed/SoftwareCPR-Newsletter021201.PDF
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ISO 14971 SaMD Risk Management

Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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