LH
L. Hoogervorst
4 records found
1
Background: Orthopaedic Data Evaluation Panel (ODEP) ratings of total hip (TH) and total knee (TK) implants are informative for assessing implant performance. However, the validity of ODEP ratings across multiple registries is unknown. Therefore, we aimed to assess, across multip
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The reliability of revision rates following primary shoulder arthroplasty as a quality indicator to rank hospital performance
A national registry analysis including 13,104 shoulders and 87 hospitals
Background: To assess the extent of between-hospital variation in revision following primary shoulder arthroplasty (SA), both overall and for specific revision indications to guide quality improvement initiatives, and to assess whether revision rates are suitable as quality indic
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Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of
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Improved clinical investigation and evaluation of high-risk medical devices
The rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)
In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing
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