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Items: 1 to 20 of 240

1.

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. doi: 10.1371/journal.pmed.1001276. Review.

2.

Improving medical device regulation: the United States and Europe in perspective.

Sorenson C, Drummond M.

Milbank Q. 2014 Mar;92(1):114-50. doi: 10.1111/1468-0009.12043.

3.

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.

4.

EU and member state medical devices regulation.

Altenstetter C.

Int J Technol Assess Health Care. 2003 Winter;19(1):228-48.

PMID:
12701954
5.

How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Samuel AM, Rathi VK, Grauer JN, Ross JS.

Clin Orthop Relat Res. 2016 Apr;474(4):1053-68. doi: 10.1007/s11999-015-4634-x.

PMID:
26584802
6.

Medical device regulation for manufacturers.

McAllister P, Jeswiet J.

Proc Inst Mech Eng H. 2003;217(6):459-67.

PMID:
14702983
7.

[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. doi: 10.1016/j.respe.2012.08.004. French.

PMID:
23477881
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12.

Assessment of cardiovascular and noncardiovascular medical device recalls.

Somberg JC, McEwen P, Molnar J.

Am J Cardiol. 2014 Jun 1;113(11):1899-903. doi: 10.1016/j.amjcard.2014.03.024.

PMID:
24837271
13.

Medical device regulation in the United States and the European Union: a comparative study.

Chai JY.

Food Drug Law J. 2000;55(1):57-80. No abstract available.

PMID:
12296349
14.

Medical device recalls and the FDA approval process.

Zuckerman DM, Brown P, Nissen SE.

Arch Intern Med. 2011 Jun 13;171(11):1006-11. doi: 10.1001/archinternmed.2011.30.

PMID:
21321283
15.

Mini-Sentinel's systematic reviews of validated methods for identifying health outcomes using administrative and claims data: methods and lessons learned.

Carnahan RM, Moores KG.

Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:82-9. doi: 10.1002/pds.2321.

PMID:
22262596
16.

The role of the U.S. Food and Drug Administration in device evaluation and monitoring.

ASGE Technology Committee., Diehl DL, Tierney WM, Adler DG, Conway JD, Farraye FA, Kantsevoy SV, Kaul V, Kethu SR, Kwon RS, Mamula P, Pedrosa MC, Rodriguez SA.

Gastrointest Endosc. 2010 Jul;72(1):5-10. doi: 10.1016/j.gie.2010.01.024. Review.

PMID:
20421100
18.

[The EU medical device market process and enlightenment for the review].

Luo Q.

Zhongguo Yi Liao Qi Xie Za Zhi. 2014 May;38(3):210-2. Chinese.

PMID:
25241519
19.

[Petition of European experts on medical products legislation].

[No authors listed]

Z Evid Fortbild Qual Gesundhwes. 2013;107(4-5):347-50. German. No abstract available.

PMID:
24066377
20.

Postmarket evaluation of breakthrough technologies.

Rao SV, Califf RM, Kramer JM, Peterson ED, Gross TP, Pepine CJ, Williams DO, Donohoe D, Waksman R, Mehran R, Krucoff MW.

Am Heart J. 2008 Aug;156(2):201-8. doi: 10.1016/j.ahj.2008.01.036.

PMID:
18657647
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