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Articles Tagged "failure mode"

Reducing the 1% Failure Rate through Testing & Analysis

by John McCloy | Mar 2017

John McCloy offers solutions to reducing the 1% failure rate of medical implants through testing & analysis... Read more »

Design Controls: Design Verification and Validation

by BONEZONE | Sep 2010

This editorial is the fifth in a series of six articles focused upon the design controls process from a standpoint of design verification and design validation in the orthopaedic medical device marketplace. First, let’s review some pertinent definitions of terms from the 21 CFR, Part 820.30 and IS... Read more »