Clinical Computing
We are working to ensure that software developed within MPB
services can comply with MDR 2017/745 when it comes into force in
May 2020. This involves setting up a system for software that
qualifies as a medical device (SaMD) that is not CE marked to be
used under a Health Institution Exemption (HIE); this has been
piloted in NMP, RSS and BIRCH. All software will be assessed and
appropriate action taken dependent on risk.
Databases have been developed and supported for areas including
radioactive waste, ARSAC, and X-Ray Quality Assurance.