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Inspection

 

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Software Mil Std Development

 

 

 

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Inspection

Points to Consider when Preparing for an FDA Inspection under the QSIT Management Controls Subsystem (HIMA / AdvaMed), revised Oct 6, 1999 (PDF)

Inspection of Medical Device Manufacturers - Final Guidance for Industry and FDA, CDRH Feb 7, 2001, CPGM 7382.845 Link to Word, PDF, HTML
Application of Design Control before June 1, 1997: see part III

Guide to Inspections of Medical Device Manufacturers,  ORA, December 1997

 

Particles

Federal Standard 209E , Sept 11, 1992 (PDF)

MIL-STD-1246C, Product Cleanliness Levels and Contamination Control Program, DOD Specifications/Standards/Guides Sep 4, 1994 (PDF)

 

Qualified person

Training providers for QP UK: Royal Chemical Society Register

 

 

Software

MIL STD 498, Software Development and Documentation, DOD Specifications/Standards/Guides, Dec 5, 1994
Download .zip-file 3.2 MB:
http://npoesslib.ipo.noaa.gov/techlib/doc191/498.zip

 

 

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