In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...

The National E-Health Transition Authority (NEHTA) is testing specifications and has almost recovered from its stumble that lead to it stopping e-health record trials, said NEHTA CEO Peter Fleming. In ...

A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference ...

This five-course series will enable the regulatory affairs professional to understand how standards, specifications, and regulations are developed for medical devices and in vitro diagnostic medical ...

Frank B¼chner of Hitex Development Tools describes how the classifications tree method can be used to transform a problem specification to a set of test case specifications. Testing is a compulsory ...