Posted by Sten Westgard, MS
A recent New York Times Sunday editorial focused on the deplorable state of medical device regulation. We simply can no longer trust FDA clearances, particularly 510ks:
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
For more than 18 years, we've been talking about Six Sigma.
Now we want to hear from you!
https://www.surveymonkey.com/r/SPSWG8Z
To help motivate you, we're offering several prizes to randomly selected survey participants. The prizes include...
-----Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
I was looking over a recent study of a compact blood gas analyzer conducted over multiple sites, multiple cartridges, multiple days, etc. In other words, this was a study that was doing a very thorough job.
Then I reached a section where suddenly it all fell to nonsense: measurement uncertainty.
So they calculated measurement uncertainty, but then they compared the results against Ricos desirable imprecision performance specifications.
Huh?
-----Posted by Sten Westgard, MS
Remember in 2017 when there were predictions that Theranos wouldn't last out the year?
It appears reports of Theranos' death were greatly exaggerated... or maybe not
-----Posted by Sten Westgard, MS [first posted on LinkedIn]