In the past decade there has been a marked increase in the application of software in Medical Devices. There are now an increasing number of Apps which can act as standalone medical devices or are part of a medical device application.
Many medicinal products use medical devices for their delivery. With the advances in hardware and software technologies many of these devices are now “intelligent” and increasingly integrated into the “Internet of things”. These devices use connectivity with 3G or 4G systems either to inform the physician or to enhance patient compliance or both.
The proliferation of the use of software in the management of medical devices has created a new departure for many in the software development community some of whom are new to developing software in a regulated area. The paper outlines the regulatory requirements in this field.
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