Medical Device Software, IEC 62304, and FDA requirements

In this section, we cover all aspects related to medical device software. You will find hints on how to effectively and efficiently fulfill the requirements by IEC 62304 and the FDA. Articles cover the entire software life cycle and respective regulations.

Software Lifecycle

The development process describes how, and in which sequence the involved roles (such as requirements engineers, programmers, architects, testers, etc.) transform inputs into outputs (e.g. plans, architectural design charts, software/code and other documentation).