Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review

Hoogervorst, LA; Geurkink, TH; Lübbeke, A; Buccheri, S; Schoones, JW; Torre, M; Laricchiuta, P; Piscoi, P; Pedersen, AB; Gale, CP; Smith, JA; Maggioni, AP; James, S; Fraser, AG; Nelissen, RGHH; de Mheen, PJM-V

Journal article

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review

Abstract:: Background Regulation and postmarket surveillance of medical devices have been criticized for being too lenient as compared to drug regulation and postmarket surveillance. Little is known about the factors that determine which medical devices are chosen for implementation among similar medical devices. Objective Our aim was to systematically identify and characterize empirical studies on medical device regulation, implementation and postmarket surveillance, and to describe the recurring theme...
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Publication status:: Published

Peer review status:: Peer reviewed

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APA Style

Hoogervorst, L. A., Geurkink, T. H., Lübbeke, A., Buccheri, S., Schoones, J. W., Torre, M., Laricchiuta, P., Piscoi, P., Pedersen, A. B., Gale, C. P., Smith, J. A., Maggioni, A. P., James, S., Fraser, A. G., Nelissen, R. G. H. H., & de Mheen, P. J. M.-V. (2023). Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review. International Journal of Health Policy and Management, 12, 7648–7648.

MLA Style

Hoogervorst, LA, et al. “Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.” International Journal of Health Policy and Management, vol. 12, 2023, pp. 7648–48.

Chicago Style

Hoogervorst, LA, TH Geurkink, A Lübbeke, et al. 2023. “Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.” International Journal of Health Policy and Management 12: 7648–48.
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