136 related articles for article (PubMed ID: 11488197)
1. US inspections of clinical investigation sites.
Donawa M
Med Device Technol; 2001 Jun; 12(5):25-8. PubMed ID: 11488197
[TBL] [Abstract][Full Text] [Related]
2. Final FDA inspection manual.
Donawa M
Med Device Technol; 2001 Apr; 12(3):29-32. PubMed ID: 11547684
[TBL] [Abstract][Full Text] [Related]
3. Complying with US nonconforming product requirements.
Donawa M
Med Device Technol; 2007; 18(3):22, 24-5. PubMed ID: 17585716
[TBL] [Abstract][Full Text] [Related]
4. US quality system requirements for software validation.
Donawa ME
Med Device Technol; 1998 Mar; 9(2):17-20. PubMed ID: 10186973
[TBL] [Abstract][Full Text] [Related]
5. Organising European technical documentation to avoid duplication.
Donawa M
Med Device Technol; 2006 Apr; 17(3):29-31. PubMed ID: 16736662
[TBL] [Abstract][Full Text] [Related]
6. FDA offers CLIA test categorization database, CMS plans inspections in waived and PPMP laboratories, and ICD.9 coding is clarified.
Pontius CA
MLO Med Lab Obs; 2001 Nov; 33(11):34, 37. PubMed ID: 11721283
[No Abstract] [Full Text] [Related]
7. Understanding US labelling requirements.
Donawa M
Med Device Technol; 2005 Sep; 16(7):21-3. PubMed ID: 16259155
[TBL] [Abstract][Full Text] [Related]
8. Lessons learned from independent central review.
Ford R; Schwartz L; Dancey J; Dodd LE; Eisenhauer EA; Gwyther S; Rubinstein L; Sargent D; Shankar L; Therasse P; Verweij J
Eur J Cancer; 2009 Jan; 45(2):268-74. PubMed ID: 19101138
[TBL] [Abstract][Full Text] [Related]
9. Change in FDA stance on Part 11 Requirements.
Donawa M
Med Device Technol; 2003 Apr; 14(3):24-6. PubMed ID: 12789696
[TBL] [Abstract][Full Text] [Related]
10. Meeting European and US requirements for design and development documentation, Part II.
Donawa ME
Med Device Technol; 1996 Dec; 7(10):10-5. PubMed ID: 10164052
[TBL] [Abstract][Full Text] [Related]
11. EC/FDA joint inspections.
Nasto B
Nat Biotechnol; 2008 Aug; 26(8):847. PubMed ID: 18688225
[No Abstract] [Full Text] [Related]
12. 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]
13. New US agent requirements.
Donawa M
Med Device Technol; 2002; 13(1):35-7. PubMed ID: 11921780
[TBL] [Abstract][Full Text] [Related]
14. Auditing device clinical studies for US requirements.
Donawa M
Med Device Technol; 2007 Oct; 18(6):24-7. PubMed ID: 18078178
[TBL] [Abstract][Full Text] [Related]
15. Medical device reporting: another final rule, Part I.
Donawa M
Med Device Technol; 2000 Mar; 11(2):40-2. PubMed ID: 10915493
[TBL] [Abstract][Full Text] [Related]
16. Europe and FDA agree to limited inspections.
Fox JL
Nat Biotechnol; 1997 Aug; 15(8):714-5. PubMed ID: 9333519
[No Abstract] [Full Text] [Related]
17. The history and contemporary challenges of the US Food and Drug Administration.
Borchers AT; Hagie F; Keen CL; Gershwin ME
Clin Ther; 2007 Jan; 29(1):1-16. PubMed ID: 17379043
[TBL] [Abstract][Full Text] [Related]
18. New FDA guidance on electronic records and signatures.
Donawa M
Med Device Technol; 2001 Nov; 12(9):32-5. PubMed ID: 12938536
[TBL] [Abstract][Full Text] [Related]
19. 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]
20. FDA regulation of the safety of MR devices: past, present, and future.
Athey TW
Magn Reson Imaging Clin N Am; 1998 Nov; 6(4):791-5. PubMed ID: 9799856
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]