Tag Archives: verification

Steve Thompson

Risk-Based CSA Validation: Ensuring the Least Burdensome Approach

By Steve Thompson
Steve Thompson

When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more effectively. The following article outlines how companies can identify the appropriate degree of testing rigor for risk-based CSA validation to ensure the least burdensome approach.

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MEDdesign

Four Ways Risk Analysis and Verification Testing Can Help Prevent Recalls

By Scott Phillips

When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.

When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.

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