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    Medical Device Risk Management by Regulatory Authorities

    Regulatory Authorities are challenged to keep their markets open and to ensure that patients have proper access to devices while at the same time keeping non-compliant, possibly dangerous devices away from their populations. To achieve this they need to use risk control strategies. Authorities that are rethinking their approaches to risk management could consider a three-tier system: A 100% check on all devices for a limited number of items per device; A more extensive...