200 related articles for article (PubMed ID: 27585362)
1. Understanding medical device regulation.
Galgon RE
Curr Opin Anaesthesiol; 2016 Dec; 29(6):703-710. PubMed ID: 27585362
[TBL] [Abstract][Full Text] [Related]
2. Legal regulation of the production and trade of medical devices and medical equipment in the EU and US: experience for Ukraine.
Pashkov V; Kotvitska A; Harkusha A
Wiad Lek; 2017; 70(3 pt 2):614-618. PubMed ID: 28713093
[TBL] [Abstract][Full Text] [Related]
3. Oversight overhaul: eliminating the premarket review of medical devices and implementing a provider-centered postmarket surveillance strategy.
Scott B
Food Drug Law J; 2011; 66(3):377-404, ii. PubMed ID: 24505854
[TBL] [Abstract][Full Text] [Related]
4. Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.
Alder HC
Hosp Technol Ser; 1993 Oct; 12(11):1-27. PubMed ID: 10129209
[TBL] [Abstract][Full Text] [Related]
5. Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.
Kramer DB; Tan YT; Sato C; Kesselheim AS
Food Drug Law J; 2014; 69(1):1-23, i. PubMed ID: 24772683
[TBL] [Abstract][Full Text] [Related]
6. [Introduction of innovative high-risk medical devices in Europe: are clinical efficacy and safety guaranteed?].
Stordeur S; Vinck I; Neyt M; Van Brabandt H; Hulstaert F
Rev Epidemiol Sante Publique; 2013 Apr; 61(2):105-10. PubMed ID: 23477881
[TBL] [Abstract][Full Text] [Related]
7. Medical device regulation for manufacturers.
McAllister P; Jeswiet J
Proc Inst Mech Eng H; 2003; 217(6):459-67. PubMed ID: 14702983
[TBL] [Abstract][Full Text] [Related]
8. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.
Rathi VK; Krumholz HM; Masoudi FA; Ross JS
JAMA; 2015 Aug; 314(6):604-12. PubMed ID: 26262798
[TBL] [Abstract][Full Text] [Related]
9. Technology assessment of medical devices at the Center for Devices and Radiological Health.
Kessler L; Richter K
Am J Manag Care; 1998 Sep; 4 Spec No():SP129-35. PubMed ID: 10185989
[TBL] [Abstract][Full Text] [Related]
10. The "déjà vu effect:" evaluation of United States medical device legislation, regulation, and the Food and Drug Administration's contentious 510(k) program.
Bauman J
Food Drug Law J; 2012; 67(3):337-61, i. PubMed ID: 24624654
[TBL] [Abstract][Full Text] [Related]
11. Early experience of the European Medical Devices Vigilance System.
Randall H
Australas Phys Eng Sci Med; 1997 Dec; 20(4):203-6. PubMed ID: 9503691
[TBL] [Abstract][Full Text] [Related]
12. How does medical device regulation perform in the United States and the European union? A systematic review.
Kramer DB; Xu S; Kesselheim AS
PLoS Med; 2012; 9(7):e1001276. PubMed ID: 22912563
[TBL] [Abstract][Full Text] [Related]
13. Medical devices: US medical device regulation.
Jarow JP; Baxley JH
Urol Oncol; 2015 Mar; 33(3):128-32. PubMed ID: 25458071
[TBL] [Abstract][Full Text] [Related]
14. Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration.
Rathi VK; Ross JS; Samuel AM; Mehra S
Otolaryngol Head Neck Surg; 2015 Sep; 153(3):400-8. PubMed ID: 26044785
[TBL] [Abstract][Full Text] [Related]
15. Regulation of medical devices in radiology: current standards and future opportunities.
Smith JJ
Radiology; 2001 Feb; 218(2):329-35. PubMed ID: 11161144
[TBL] [Abstract][Full Text] [Related]
16. What physicians should know about the regulation of Obstetric and Gynecologic Medical Devices.
Yin L
J Reprod Med; 1983 Jan; 28(1):3-11. PubMed ID: 6834344
[TBL] [Abstract][Full Text] [Related]
17. An analytical approach to identifying potential use-related issues concerning a medical device under development.
Gupta SP; Pidgeon A
J Med Eng Technol; 2016; 40(3):61-71. PubMed ID: 26795586
[TBL] [Abstract][Full Text] [Related]
18. Human factors in the design of medical devices - Approaches to meeting international standards in the European Union and USA.
Privitera MB; Evans M; Southee D
Appl Ergon; 2017 Mar; 59(Pt A):251-263. PubMed ID: 27890135
[TBL] [Abstract][Full Text] [Related]
19. Medical Device Regulation: A Comparison of the United States and the European Union.
Maak TG; Wylie JD
J Am Acad Orthop Surg; 2016 Aug; 24(8):537-43. PubMed ID: 27195383
[TBL] [Abstract][Full Text] [Related]
20. [Better medical devices regulations for better health care: enlightenment for medical devices regulatory reform in China, from experiences of the E.U. and the U.S.A].
Sun Q; Yan L
Zhongguo Yi Liao Qi Xie Za Zhi; 2006 Jan; 30(1):43-52. PubMed ID: 16646425
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
