Blog
Forums

Design Verification (Product Testing)

STAT-12: Verification/Validation Sampling Plans for Proportion Nonconforming

45 Comments / Audits and Effectiveness Checks, Design Validation (Clinical and User Testing), Design Verification (Product Testing), Process Validation (Process and Supplier Testing), Validation Sampling Plans / By

This is part of a series of articles covering the procedures in the book Statistical Procedures for the Medical Device Industry. Purpose This procedure provides tables and instructions for selecting sampling plans for FDA process validation and design verification to ensure they are based on a valid statistical rationale.  These determine the samples size and acceptance […]

STAT-12: Verification/Validation Sampling Plans for Proportion Nonconforming Read More »

STAT-04: Statistical Techniques for Design Verification

43 Comments / Design Verification (Product Testing) / By

This is part of a series of 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

STAT-04: Statistical Techniques for Design Verification Read More »

Subscribe to our Email List

Copyright © 2019 Taylor Enterprises | All rights reserved.

Scroll to Top