Design Completion Checklist for Non-Electromechanical Devices


Product Name:                                 Model:                                      

Project Leader:                               Date:                                        



ITEM                           COMMENTS*

 1)  Product Specification -
 2)  Performance Factors -
 - 
 3)  Accuracy -
 4)  Precision -
 5)  Specificity -
 6)  Sensitivity -
 7)  Range -
 8)  Linearity -
 9)  Shelf-life Studies -
10)  Preservative Performance -
11)  Reconstitution Studies -
12)  Temperature Tolerance Test -
13)  Humidity Tolerance Test -
14)  Shipping Test -
15)  Verified Standards/Controls
       Re Low, Normal & High Values -
16)  Inner Containers -
17)  Outer Packaging -
18)  Package Insert -
19)  Process Validation -
20)  Processing Procedures -
21)  Verified Test and Inspection Procedures -
22)  Data Forms -
23)  Finished Dev. Storage -
24)  Purchase Specifications -
25)  Vendor Evaluations -
26)  510(k) or IDE/PMA Submission -









                                                         




* 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.