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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).
Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P; CORE-MD Investigators. Fraser AG, et al. Among authors: melvin t. Eur Heart J Qual Care Clin Outcomes. 2022 May 5;8(3):249-258. doi: 10.1093/ehjqcco/qcab059. Eur Heart J Qual Care Clin Outcomes. 2022. PMID: 34448829 Free PMC article.
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).
Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P; CORE–MD Investigators (see Appendix). Fraser AG, et al. Among authors: melvin t. EFORT Open Rev. 2021 Oct 19;6(10):839-849. doi: 10.1302/2058-5241.6.210081. eCollection 2021 Oct. EFORT Open Rev. 2021. PMID: 34760284 Free PMC article. Review.
European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children.
Guerlich K, Patro-Golab B, Barnacle A, Baumann U, Eicken A, Fraser AG, Gruszfeld D, Haas NA, Jonker AH, Kammermeier M, Kenny D, Kolaček S, Lapatto R, Maconochie I, Mader S, McGauran G, Melvin T, Muensterer O, Piscoi P, Romano A, Saxena AK, Schneider DT, Turner MA, Walle JV, Koletzko B; European Academy of Paediatrics. Guerlich K, et al. Among authors: melvin t. Acta Paediatr. 2023 Nov;112(11):2440-2448. doi: 10.1111/apa.16919. Epub 2023 Aug 15. Acta Paediatr. 2023. PMID: 37485905
Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium.
Siontis GCM, Coles B, Häner JD, McGovern L, Bartkowiak J, Coughlan JJ, Spirito A, Galea R, Haeberlin A, Praz F, Tomii D, Melvin T, Frenk A, Byrne RA, Fraser AG, Windecker S; CORE-MD Investigators. Siontis GCM, et al. Among authors: melvin t. Eur Heart J. 2024 Jan 14;45(3):161-177. doi: 10.1093/eurheartj/ehad567. Eur Heart J. 2024. PMID: 37638967 Free article.
Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers.
Hoogervorst LA, Ren Y, Melvin T, Stratton-Powell AA, Lübbeke A, Geertsma RE, Fraser AG, Nelissen RGHH, Caiani EG, Marang-van de Mheen PJ. Hoogervorst LA, et al. Among authors: melvin t. Acta Orthop. 2024 Nov 25;95:667-676. doi: 10.2340/17453674.2024.42361. Acta Orthop. 2024. PMID: 39584822 Free PMC article.
101 results