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.
The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
How to prepare for a successful transition.
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.