Quality Requirements and Standards
There are some who say bias doesn't exist. There are others who say bias is just a variance. Here, we explore the fantasy world that they live in.
May 6th 2024 will forever be etched into the history of regulation. It's the date that the FDA issued its Final Rule on Laboratory-Developed Tests (LDTs). This is the introduction to this momentous, some might say monstrous, occurrence.
As Yogi Bera once said, "In theory, there is no difference between theory and practice - in practice, there is." So is it true with mu.
The biggest change in the Prague conference on quality may be a shifting of goalposts.
It's becoming something of a trend in Europe: lowering standards, postponing implementation of standards, and inventing new reasons why the rules don't apply.