As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.”

As a medical writer drafting clinical evaluation reports for medical devices and related regulatory documentation, it is extremely important to be fully aware of the implications of medical device software evaluations. In today’s medical devices, software is becoming more and more present, and very often, software is integrated into hardware devices to enable them to achieve their medical purpose. In late 2019, I attended a thorough training course called Software as a Medical Device which helped me understand how complex the field of health software is becoming.

Alison McIntosh (editor), Stephen Gilliver (editor)