RAIDIR Proposal for Regulatory Services

ETHOS Ltd has recently been engaged to explore providing Clinical Risk Management services relating to compliance with DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems and UK MDR 2002. RAIDR is the UK's leading health intelligence tool and is used throughout the country. It underpins our approach to Population Health Management using advanced analytical techniques which link and aggregate data to provide comprehensive cohort analysis. RAIDR puts you in total control, with all the information you need at your fingertips allowing sophisticated navigation, manipulation, and the exploration of multiple datasets. There is a regulatory requirement to support the classification of RAIDR dashboards as a class one medical device. To support the ongoing development of the RAIDR dashboards there is a requirement to build up the internal skills and knowledge to support this ongoing requirement. Essential skills do you need from the supplier in order for you to complete the project successfully: • Knowledge of NHS clinical safety standards DCB0129 and DCB0160 • Understanding of MHRA medical device standards and regulations