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Safety cases for medical devices and health information technology: Involving health-care organisations in the assurance of safety
2013
Health Informatics Journal
In the UK, there are more than 9,000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the US have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area,
doi:10.1177/1460458212462079
pmid:23981393
fatcat:3qpvtee2wfdznndxwcydyktuly