Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

Early Completion of Model-Assisted Designs for Dose-Finding Trials Accurate assessment of a molecular classifier that guides patient care is of paramount importance in precision oncology. Recent years ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...