Primer on medical device regulation. Part I. History and background.
1997; Radiological Society of North America; Volume: 205; Issue: 1 Linguagem: Inglês
10.1148/radiology.205.1.9314952
ISSN1527-1315
Autores Tópico(s)Clinical practice guidelines implementation
ResumoHomeRadiologyVol. 205, No. 1 Next Primer on medical device regulation. Part I. History and background.L H MonseinL H MonseinL H MonseinPublished Online:Oct 1 1997https://doi.org/10.1148/radiology.205.1.9314952MoreSectionsPDF ToolsAdd to favoritesCiteTrack CitationsPermissionsReprints ShareShare onFacebookXLinked In Article HistoryPublished in print: 1997 FiguresReferencesRelatedDetailsCited ByUtilization of innovative medical technologies in German inpatient care: does evidence matter?HeleneEckhardt, SusanneFelgner, MarieDreger, SabineFuchs, HannaErmann, HendrikjeRödiger, TanjaRombey, ReinhardBusse, CorneliaHenschke, DimitraPanteli2 October 2023 | Health Research Policy and Systems, Vol. 21, No. 1A COMPARATIVE STUDY OF MEDICAL DEVICES AND THEIR REGULATIONS IN US, EU, INDIA, AND CHINANAGA SWAROOPAS, VENKATESWARA RAJUK, PRASANTHINL2023 | Asian Journal of Pharmaceutical and Clinical ResearchTranslational SurgeryMackinzie A.Stanley, Carol A.Lin2023Likelihood Ratio Test Method for Multiple Medical Devices Comparison Using Multiple-Site Data with Continuous OutcomesTingtingHu, JianjinXu, LanHuang, ZhihengXu, ZhihaoYao, RamTiwari2020 | Therapeutic Innovation & Regulatory Science, Vol. 54, No. 6Comprehensive BiotechnologyJeroen HM.Bergmann, RitaHendricusdottir, RegentLee2019Synthetic sutures: Clinical evaluation and future developmentsRoxanna EAbhari, Joana AMartins, Hayley LMorris, Pierre-AlexisMouthuy, AndrewCarr2017 | Journal of Biomaterials Applications, Vol. 32, No. 3Understanding medical device regulationRichard E.Galgon2016 | Current Opinion in Anaesthesiology, Vol. 29, No. 6Medical Device Regulation: A Comparison of the United States and the European UnionTravis G.Maak, James D.Wylie2016 | Journal of the American Academy of Orthopaedic Surgeons, Vol. 24, No. 8Medical devices: US medical device regulationJonathan P.Jarow, John H.Baxley2015 | Urologic Oncology: Seminars and Original Investigations, Vol. 33, No. 3Medical device assessment: scientific evidence examined by the French national agency for health – a descriptive studyLaureHuot, EvelyneDecullier, KarenMaes-Beny, Francois RChapuis2012 | BMC Public Health, Vol. 12, No. 1Biomaterials for Spinal SurgeryB.Alcock2012The role of the U.S. Food and Drug Administration in device evaluation and monitoringDavid L.Diehl, William M.Tierney, Douglas G.Adler, Jason D.Conway, Francis A.Farraye, Sergey V.Kantsevoy, VivekKaul, Sripathi R.Kethu, Richard S.Kwon, PetarMamula, Marcos C.Pedrosa, Sarah A.Rodriguez2010 | Gastrointestinal Endoscopy, Vol. 72, No. 1Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology AssessmentMitchell D.Feldman, Amy J.Petersen, Leah S.Karliner, Jeffrey A.Tice2008 | Journal of General Internal Medicine, Vol. 23, No. S1Introduction to the MAUDE DatabaseSHAWN E.GURTCHEFF2008 | Clinical Obstetrics & Gynecology, Vol. 51, No. 1Monitoring Device Safety in Interventional CardiologyM. E.Matheny, L.Ohno-Machado, F. S.Resnic2006 | Journal of the American Medical Informatics Association, Vol. 13, No. 2Evaluating Devices for Treating EpilepsyBrianLitt12 August 2003 | Epilepsia, Vol. 44, No. s7Foreign materials in tissues: pathogenesis and clinical implicationsW.F.Ng2003 | Current Diagnostic Pathology, Vol. 9, No. 2Regulation of Medical Devices in Radiology: Current Standards and Future Opportunities1John J. Smith, 1 February 2001 | Radiology, Vol. 218, No. 2FDA REGULATION OF THE SAFETY OF MR DEVICEST. WhitAthey1998 | Magnetic Resonance Imaging Clinics of North America, Vol. 6, No. 4Recommended Articles RSNA Education Exhibits RSNA Case Collection Vol. 205, No. 1 Metrics Altmetric Score PDF download
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