Clinical investigations and clinical evaluation strategies.
It is accepted that no device that is clinically effective is entirely without hazard, and not all hazards can be known before a device is marketed. This article outlines the strategies to adopt when evaluating the benefit-risk ratios of high-risk medical devices.
O'Dwyer
John
J
Medical Device Department, National Standards Authority of Ireland, Glasnevin, Dublin 9, Ireland. john.odwyer@nsai.ie
D018795:Device Approval; D004868:Equipment Failure; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards*; D005062:European Union; D006801:Humans; D007318:Inservice Training / Q000458:organization & administration; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment / Q000379:methods*