Design and Development of Medical Devices

Abstract

The medical device industry is one of the fastest growing industries. Medical devices cover a wide range of products for medical use, ranging from the simplest to the most sophisticated medical equipment. Thanks to today’s rapid development in both medicine and technology, the development of medical devices has been intensified. Given the multidisciplinary characteristics of such devices and their environment, the process of developing medical devices involves some special characteristics. Due to their potentially harmful effects in the interaction with tissues and organs, compliance with the various directives is of particular importance. For these reasons, it is necessary to carefully follow all steps in the design and manufacture of medical devices in order to obtain regulatory approval and licensing of the products, so that their implementation is safe for users. This paper demonstrates that medical device design is a unique and complex process which requires an organized development strategy that ensures that the product meets design and user goals, is technically reliable, and can be produced safely and efficiently.