Finished Product Release


Product Name:                                 Model:                                      

Project Leader:                               Date:                                        



DOCUMENTATION                  COMMENTS*

 1)  Master Record Index -
 2)  Device Master Record -
       (Overall Review)
 3)  Verified Device Specifications -
 4)  Verified Test and Inspection Procedures -
 5)  Production Validation Documentation -
 6)  Labels, Artwork -
 7)  Packaging -
 8)  Purchase Specifications -
 9)  Vendor Evaluations -
10)  SOP & QA Manual References -

MANUFACTURING

 1)  Equipment Qualification -
 2)  Personnel Training -
 3)  Process Validation -
 4)  Pilot Production -
 5)  Pilot Release -

REGULATORY

 1)  FDA Premarket Approval
 -
 -
 -

SERVICE

 1)  Servicing Plan -
 2)  Personnel Trained -
 -
 -









* The following abbreviations may be used in the comment column to save time.

U  = Unsatisfactory NA = Not Applicable
NI = Needs ImprovementS    = Satisfactory

Attach Additional sheets for comment explanation if necessary.