Twenty-five years ago, software did not feature significantly in medical device legislation. Thirteen years ago it was added as a serious afterthought. As Europe moves to the new Medical Device Regulations, software is recognised throughout the General Safety and Performance Requirements. It has its own rules in classification, whether it is software as a medical device or
software as the driver of a medical device. Software has come to the attention of the regulators as a serious source of risk and benefit. This sequence of seminars aims to help those involved in medical device software to understand intricacies of the regulatory burden and how early adoption of the solutions minimises both the costs and time to market.