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
In Biochemia Medica, a recent article detailed the Minimum requirements for the estimation of measurement uncertainty:Recommendations of the joint Working group for uncertainty of measurement of the CSMBLM and CCMB.
Can you guess how many?
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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
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
My esteemed colleague, good friend, and keen-eyed tracker of all things regulatory. Dr. Sharon Ehrmeyer, alerted me to a HUGE change in US regulations.
In April CMS sent out a memo title "Policy Clarification on Acceptable Control Materials Used when Quality Control (QC) is Performed in Laboratories"
This memo may contain as big a shift in regulatory policy as IQCP was to EQC. More, after the jump...
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