Medical device design process

Abstract

The current design process is a combination of methods from engineering disciplines, government regulatory agencies (domestic and international) and independent certification and compliance companies. The goal of the processes that have been developed is to be certain that a new product meets the users expectations, is safe and effective in providing its claimed benefits. As products have become more complex and particularly with regard to software control it has become increasingly more difficult to determine the safety and efficacy of a product by inspection or after the fact testing alone. In order to improve the ability of designers and auditors to ascertain the safety and efficacy of a product, the use of design controls has been adopted that specify a method of evaluating the design process at several key stages. This paper will describe some of the methods that are used for design controls intending to give the reader an overview of these methods in the context of medical products.