ABSTRACT

This chapter looks at a few of the most current topics relating to the development and maintenance of medical software the people see being discussed across the world. Usability engineering is a fundamental activity with implications for several of the software development life-cycle phases discussed elsewhere in this book. In the short term cybersecurity will probably have a much greater impact on medical devices than artificial intelligence as it touches on just about all medical-device software whereas artificial intelligence is still in many ways more of a promise than a practice. Chief among the standards are the ISO 13485 standard on quality management, ISO 14971 on risk management in medical devices and the IEC 62304 standard on software life-cycle processes, all of which the people have discussed in this book. All forms of cloud computing, including the proliferation of so-called Software-as-a-Service (SaaS) tools and services, have taken over the world of computation.