New software group at European Commission:
This article was originally published in Clinica
Executive Summary
The European Commission's Medical Devices Experts Group has set up a new working group on medical device software. The group will focus on issues including: risk management guidance for medical software; guidance for notified bodies involved in software assessment; the quality of European medical software standards; software design; the quality of European medical software standards; quality assurance throughout the software life cycle; including updates; design validation within conformity assessment procedures for medical devices; and validation of commercial, off-the-shelf software for medical appliances.