“If it isn’t documented, it didn’t happen” is one of the FDA’s
best-known unwritten rules. As the agency’s resources are already
stretched thin, the medical device industry is being held to an ever-higher standard of data collection.
With accurate and comprehensive computer-aided inspection (CAI) you can
satisfy regulators by recording and documenting every surface data
point and every extracted dimension for future reference — while cutting
iterations, months, and millions of dollars from the process
development schedule. The same can hardly be said for fixed gauges or