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Articles Tagged "specification"

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 »

Design Controls: Inputs and Outputs in Synergy

by BONEZONE | Mar 2010

This is the third in a series of articles focused on the design controls process from a standpoint of business acumen as well as meeting customer requirements in the orthopaedic medical device market. Sometimes called the requirements phase, design inputs are the starting point of understanding the ... Read more »