461 related articles for article (PubMed ID: 11547684)
21. Successful recruitment for medical device clinical studies.
Donawa M
Med Device Technol; 2004 Oct; 15(8):25-7. PubMed ID: 16225270
[TBL] [Abstract][Full Text] [Related]
22. Preparing for an FDA preapproval inspection.
Blackmer RA
Qual Assur; 1994 Dec; 3(4):389-403. PubMed ID: 7613749
[TBL] [Abstract][Full Text] [Related]
23. Meeting US and European supplier control requirements.
Donawa M
Med Device Technol; 2009; 20(3):24-7. PubMed ID: 19626952
[TBL] [Abstract][Full Text] [Related]
24. Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices), guidance for FDA reviewers and industry; availability--FDA. Notice.
Fed Regist; 1998 Nov; 63(215):60009-10. PubMed ID: 10187389
[TBL] [Abstract][Full Text] [Related]
25. Medical device regs: are they doing the job? FDA and industry share common goal of device safety.
McDonnell EJ
AORN J; 1981 Apr; 33(5):949-54. PubMed ID: 6908513
[No Abstract] [Full Text] [Related]
26. 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]
27. FDA final guidance on software validation.
Donawa M
Med Device Technol; 2002 Apr; 13(3):20-4. PubMed ID: 12030100
[TBL] [Abstract][Full Text] [Related]
28. When to conduct a clinical trial.
Boutrand JP
Med Device Technol; 2004 Oct; 15(8):28-31. PubMed ID: 16225271
[TBL] [Abstract][Full Text] [Related]
29. Conducting clinical studies in Italy.
Donawa M
Med Device Technol; 2005 Oct; 16(8):21-4. PubMed ID: 16355966
[TBL] [Abstract][Full Text] [Related]
30. FDA issues final enforcement priorities for reprocessed medical devices.
Hosp Outlook; 2000 Sep; 3(7):7, 12. PubMed ID: 11142987
[No Abstract] [Full Text] [Related]
31. Coping with CLIA, Part 7. Walking the straight and narrow on quality control.
Passey RB
MLO Med Lab Obs; 1993 Feb; 25(2):39-43. PubMed ID: 10171371
[No Abstract] [Full Text] [Related]
32. FDA import alert: a potentially devastating enforcement tool.
Basile EM
Med Device Technol; 1998 Apr; 9(3):34-8. PubMed ID: 10179199
[TBL] [Abstract][Full Text] [Related]
33. US regulation of combination products.
Donawa M
Med Device Technol; 2009 Oct; 20(6):22, 24-5. PubMed ID: 20302139
[TBL] [Abstract][Full Text] [Related]
34. A US FDA medical device update, Part II.
Donawa ME
Med Device Technol; 1996 Sep; 7(7):12-6, 18. PubMed ID: 10163518
[TBL] [Abstract][Full Text] [Related]
35. US manufacturing guideline for IVD products.
Donawa M
Med Device Technol; 2000 Oct; 11(8):23-4. PubMed ID: 11185183
[TBL] [Abstract][Full Text] [Related]
36. How do regulatory agencies ensure the release of a safe medical device?
Haggar B
Clin Perform Qual Health Care; 1999; 7(2):100-3. PubMed ID: 10747561
[TBL] [Abstract][Full Text] [Related]
37. Medical device warning letter draft pilot; availability--FDA. Notice.
Fed Regist; 1998 Aug; 63(166):45821-5. PubMed ID: 10182695
[TBL] [Abstract][Full Text] [Related]
38. Useful US guidance on device software.
Donawa M
Med Device Technol; 2005 Dec; 16(10):18-20. PubMed ID: 16419920
[TBL] [Abstract][Full Text] [Related]
39. New US agent requirements.
Donawa M
Med Device Technol; 2002; 13(1):35-7. PubMed ID: 11921780
[TBL] [Abstract][Full Text] [Related]
40. Controlling the quality of raw materials.
Donawa ME
Med Device Technol; 1998; 9(1):12-5. PubMed ID: 10176139
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
