FDA’s Five Year Plan: Scientific Computing Initiative

At first glance, the FDA’s Scientific Computing Initiative might appear to concern only clinical data, but as the medical device industry continues to modernize its quality systems and harmonize engineering data with clinical outcomes in the still-evolving approval process, the FDA’s interest in inspection results isn’t likely to decrease.

Accurate and comprehensive computer-aided inspection (CAI) redefines standards by allowing manufacturers to build a vast and ever-growing repository of information about their products — while cutting iterations, months, and millions of dollars from the process development schedule.