112 related articles for article (PubMed ID: 22916485)
1. [Discourse of requirement for facility & environment in medical device quality system].
Lü H
Zhongguo Yi Liao Qi Xie Za Zhi; 2012 May; 36(3):218-21. PubMed ID: 22916485
[TBL] [Abstract][Full Text] [Related]
2. Medical devices; current good manufacturing practice (CGMP) final fule; quality system regulation--FDA. Final rule.
Fed Regist; 1996 Oct; 61(195):52602-62. PubMed ID: 10168287
[TBL] [Abstract][Full Text] [Related]
3. [Analysis on current laws and regulations of medical device clinical trial in China].
Wang Y; Li T; Liang N
Zhongguo Yi Liao Qi Xie Za Zhi; 2014 Jan; 38(1):61-4. PubMed ID: 24839854
[TBL] [Abstract][Full Text] [Related]
4. Devices and desires: industry fights toughening of medical device regulation in Europe.
Cohen D
BMJ; 2013 Oct; 347():f6204. PubMed ID: 24133129
[No Abstract] [Full Text] [Related]
5. [Medical device registration system comparison between China and U.S.A].
Yue W
Zhongguo Yi Liao Qi Xie Za Zhi; 2009 Jan; 33(1):51-8. PubMed ID: 19459353
[TBL] [Abstract][Full Text] [Related]
6. Medical devices; establishment registration and device listing for manufacturers and distributors of devices; correction--FDA. Proposed rule; correction.
Fed Regist; 1998 Nov; 63(228):65566. PubMed ID: 10338876
[TBL] [Abstract][Full Text] [Related]
7. Achieving systematic compliance with the Medical Device Directive.
Lally R
Med Device Technol; 1996 Sep; 7(7):28-33. PubMed ID: 10172791
[TBL] [Abstract][Full Text] [Related]
8. Software process improvement for the medical industry.
McCaffery F; Donnelly P; McFall D; Wilkie FG
Stud Health Technol Inform; 2005; 117():117-24. PubMed ID: 16282661
[TBL] [Abstract][Full Text] [Related]
9. Perspectives on the U.S. FDA Bioresearch Monitoring Program.
Gamet JE
Qual Assur; 1995 Mar; 4(1):12-9. PubMed ID: 8520859
[TBL] [Abstract][Full Text] [Related]
10. Medical device warning letter pilot. Food and Drug Administration, HHS. Notice.
Fed Regist; 1999 Mar; 64(44):11018-23. PubMed ID: 10557622
[TBL] [Abstract][Full Text] [Related]
11. Industry perspective on FDA regulation of medical devices and the practice of medicine.
Tandy MK
Ann Thorac Surg; 1996 Jan; 61(1):485-6; discussion 493-8. PubMed ID: 8561635
[No Abstract] [Full Text] [Related]
12. [Standards used in the regulation of medical device in USA].
Hu W; Gu H
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi; 2007 Nov; 21(11):1263-7. PubMed ID: 18069490
[TBL] [Abstract][Full Text] [Related]
13. Medical devices on trial, Part I.
Wright D
Med Device Technol; 2002 Dec; 13(10):35-8. PubMed ID: 12575529
[TBL] [Abstract][Full Text] [Related]
14. Medical devices; reconditioners, rebuilders of medical devices; revocation of compliance policy guide; request for comments--FDA. Notice.
Fed Regist; 1998 Dec; 63(233):67076-8. PubMed ID: 10338883
[TBL] [Abstract][Full Text] [Related]
15. Medical devices; establishment registration and device listing for manufacturers and distributors of devices; correction--FDA. Direct final rule; correction.
Fed Regist; 1998 Nov; 63(228):65554-5. PubMed ID: 10338874
[TBL] [Abstract][Full Text] [Related]
16. Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; pharmaceutical GMP inspection reports, medical device quality system evaluation reports, and certain medical device premarket evaluation reports--FDA. Proposed rule.
Fed Regist; 1998 Apr; 63(69):17744-71. PubMed ID: 10177764
[TBL] [Abstract][Full Text] [Related]
17. Validation of environmental monitoring methods and levels.
Noble NH
J Parenter Sci Technol; 1993; 47(1):26-8. PubMed ID: 8445496
[TBL] [Abstract][Full Text] [Related]
18. [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]
19. The review of the RoHS Directive.
Howes K
Med Device Technol; 2006; 17(9):24, 26. PubMed ID: 17240683
[TBL] [Abstract][Full Text] [Related]
20. [Comparative study of device labeling regulation in U.S.A. and China].
Li F; Wei J; Ma Y; Li Z
Zhongguo Yi Liao Qi Xie Za Zhi; 2010 Sep; 34(5):374-7. PubMed ID: 21179718
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
