-
1
-
-
84958255099
-
Analysis and classification of medical device recalls
-
Springer
-
B. Zhivko, G. Mitalas, and N. Pallikarakis, "Analysis and Classification of Medical Device Recalls," Proc. Int'l Federation Medical and Biological Engineering, Springer, 2006, pp. 3782-3785.
-
(2006)
Proc. Int'l Federation Medical and Biological Engineering
, pp. 3782-3785
-
-
Zhivko, B.1
Mitalas, G.2
Pallikarakis, N.3
-
2
-
-
84881500613
-
Medical device databases
-
5 Mar.
-
"Medical Device Databases," US Food and Drug Administration, 5 Mar. 2013; www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ default.htm.
-
US Food and Drug Administration
, vol.2013
-
-
-
3
-
-
72549093937
-
Failure modes in medical device software: An analysis of 15 years of recall data
-
D. Wallace and D. Kuhn, "Failure Modes in Medical Device Software: An Analysis of 15 Years of Recall Data," Int'l J. Reliability Quality and Safety Eng., vol. 8, no. 4, 2001, pp. 351-372.
-
(2001)
Int'l J. Reliability Quality and Safety Eng.
, vol.8
, Issue.4
, pp. 351-372
-
-
Wallace, D.1
Kuhn, D.2
-
5
-
-
0035880307
-
Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators
-
W.H. Maisel et al., "Recalls and Safety Alerts Involving Pacemakers and Implantable Cardioverter-Defibrillator Generators," J. American Medical Assoc., vol. 286, no. 7, 2001, pp. 793-799. (Pubitemid 33015572)
-
(2001)
Journal of the American Medical Association
, vol.286
, Issue.7
, pp. 793-799
-
-
Maisel, W.H.1
Sweeney, M.O.2
Stevenson, W.G.3
Ellison, K.E.4
Epstein, L.M.5
-
7
-
-
84864058685
-
Security and privacy qualities of medical devices: An analysis of FDA postmarket surveillance
-
D.B. Kramer et al., "Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance," PLoS ONE, vol. 7, no. 7, 2012, pp. 1-7.
-
(2012)
PLoS ONE
, vol.7
, Issue.7
, pp. 1-7
-
-
Kramer, D.B.1
-
8
-
-
84881536344
-
Guidance for industry and FDA staff - Total product life cycle: Infusion pump - Premarket notification [510(k)] submissions
-
Apr.
-
Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions," US Food and Drug Administration, Apr. 2010; www.fda.gov/medicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm206153.htm.
-
(2010)
US Food and Drug Administration
-
-
-
10
-
-
53349095708
-
SymPLFIED: Symbolic program-level fault injection and error detection framework
-
IEEE
-
K. Pattabiraman et al., "SymPLFIED: Symbolic Program- Level Fault Injection and Error Detection Framework," Proc. IEEE Int'l Conf. Dependable Systems and Networks (DSN), IEEE, 2008, pp. 472-481.
-
(2008)
Proc. IEEE Int'l Conf. Dependable Systems and Networks (DSN)
, pp. 472-481
-
-
Pattabiraman, K.1
-
11
-
-
78649383888
-
Automated derivation of application-aware error detectors using static analysis: The trusted illiac approach
-
K. Pattabiraman, Z. Kalbarczyk, and R.K. Iyer, "Automated Derivation of Application-Aware Error Detectors Using Static Analysis: The Trusted Illiac Approach," IEEE Trans. Dependable and Secure Computing, vol. 8, no. 1, 2011, pp. 44-57.
-
(2011)
IEEE Trans. Dependable and Secure Computing
, vol.8
, Issue.1
, pp. 44-57
-
-
Pattabiraman, K.1
Kalbarczyk, Z.2
Iyer, R.K.3
-
12
-
-
84881536445
-
External defibrillator improvement initiative
-
Nov.
-
"External Defibrillator Improvement Initiative," US Food and Drug Administration, Nov. 2010; www.fda.gov/downloads/MedicalDevices/ ProductsandMedicalProcedures/CardiovascularDevices/ExternalDefibrillators/ UCM233824.pdf.
-
(2010)
US Food and Drug Administration
-
-
-
13
-
-
84881488211
-
Pulse oximeters-Premarket notification submissions [510(k)s] guidance for industry and FDA staff
-
Mar.
-
"Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and FDA Staff," US Food and Drug Administration, Mar. 2013; www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ ucm341718.htm.
-
(2013)
US Food and Drug Administration
-
-
-
14
-
-
33645964616
-
A formal methods approach to medical device review
-
R. Jetley, S.P. Iyer, and P.L. Jones, "A Formal Methods Approach to Medical Device Review," Computer, vol. 39, no. 4, 2006, pp. 61-67.
-
(2006)
Computer
, vol.39
, Issue.4
, pp. 61-67
-
-
Jetley, R.1
Iyer, S.P.2
Jones, P.L.3
-
15
-
-
78650281076
-
Assurance cases in model driven development of the pacemaker software
-
E. Jee, I. Lee, and O. Sokolsky, "Assurance Cases in Model Driven Development of the Pacemaker Software," Leveraging Applications of Formal Methods, Verification, and Validation, LNCS 6416, 2010, pp. 343-356.
-
(2010)
Leveraging Applications of Formal Methods, Verification, and Validation, LNCS
, vol.6416
, pp. 343-356
-
-
Jee, E.1
Lee, I.2
Sokolsky, O.3
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