This is part of a series or articles covering the procedures in the book Statistical Procedures for the Medical Device Industry

Purpose

Design verification studies are confirmatory studies to ensure the product design performs as intended. They make pass/fail decisions as to whether the product's design outputs (specifications, drawings) ensure each design input requirement (requirements definition document) is met or not. The procedure determines which design requirements require statistical methods to verify them and then helps to select the best method.

Appendices

     None

Highlights

   Sometimes Statistical Methods are not Required - When no variation

  There are Several Alternatives to Sampling Plans - When there is variation

  Instructions for Selecting Sampling Plans 

   Strategies for Reducing the Sample Size - For when a sampling plan is used