...combines the expertise of three research groups at the University of Sheffield: Rehabilitation and Assistive Technology Group (RAT Group), the Centre for Assistive Technology and Connected Healthcare (CATCH) and the Telehealth and Care Technologies theme of CLAHRC YH (http://clahrc-yh.nihr.ac.uk/)
Friday, 11 April 2014
MHRA guidance on medical device stand-alone software
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued guidance for healthcare and medical software developers who are unsure of regulatory requirements.
The guidance is for healthcare workers and device manufacturers. It outlines current regulations, defines what a medical device is, gives examples to help you understand if your device is standalone software or an app, provides information about how to meet regulations and also provides links to other sources of useful information.