-
ap962 replied to the topic Design validation in the forum Project Management Process and Medical Device Development 7 years ago
Design Validation is carried out by by examination and provision of objective evidence that ensures that device specifications conform with user needs and intended uses. It includes testing of production units under actual or simulated use conditions, software validation and risk analysis.
It is important in Project Management as design verification is a detailed examination of aspects of a design at various stages in the development but, design validation is a cumulative summation of all efforts to assure that the design will conform with user needs and intended use(s), given expected variations in
components, materials, manufacturing processes, and the use environment.