A Different Animal


I have spent my career in industry in R&D in a quality role. As I continue to interact with people that deal with quality in the in vitro diagnostics industry, I get the impression that most of these people are not from R&D but rather from regulatory affairs. What’s the difference? My perception is that regulatory affairs professionals focus more on compliance – I have focused on measuring things. Compliance is often assessed through audits with documentation a large part of audits. Measuring things forces activities to focus on improving the metric of interest. Documentation is of less importance.

What’s another difference? Whenever I write an article for publication on quality, it’s reviewed by regulatory affairs professionals. I can tell by the comments (e.g., they disagree with most of what I say). R&D people agree with me.


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