TL13: Precision studies for In-vivo devices
*Bipasa Biswas, FDA Keywords: Repeatability, Reproducibility, CLSI, ISO Many in-vivo diagnostic devices provide measurements on a continuous scale and thus precision of these devices as part of measurement validation is an important aspect of the device evaluation. Experimental designs, factors, and mathematical models to evaluate repeatability, intermediate reproducibility and reproducibility for such devices will be discussed. The CLSI documents EP05-A3 and the ISO documents 5725 discuss various designs for laboratory tests which can lend to the studies for in-vivo diagnostic devices.
|
Key Dates
-
June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC