133 related articles for article (PubMed ID: 25168841)
1. [Legal basis and practice of examination of critical in vitro diagnostic devices].
Nübling CM; Nick S
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2014 Oct; 57(10):1203-8. PubMed ID: 25168841
[TBL] [Abstract][Full Text] [Related]
2. [Safety of in-vitro diagnostics used in transfusion medicine. Experience of the BfArM until end 2005].
Siekmeier R; Halbauer J; Wetzel D
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2007 Oct; 50(10):1240-8. PubMed ID: 17924068
[TBL] [Abstract][Full Text] [Related]
3. [Diagnostic kits in parasitology: which controls?].
Rossi P
Parassitologia; 2004 Jun; 46(1-2):145-9. PubMed ID: 15305705
[TBL] [Abstract][Full Text] [Related]
4. The new European directive on in vitro diagnostics.
Dati F
Clin Chem Lab Med; 2003 Oct; 41(10):1289-98. PubMed ID: 14580154
[TBL] [Abstract][Full Text] [Related]
5. [Safety of high risk in vitro diagnostic medical devices : international and national measures].
Halbauer J; Siekmeier R; Funk M
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2009 Jun; 52(6):610-8. PubMed ID: 19421725
[TBL] [Abstract][Full Text] [Related]
6. [Are test systems for diagnostics of infectious diseases safe? Experiences of the BfArM based on all notifications received until end of 2005].
Siekmeier R; Lütz J; Wetzel D
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2008 Feb; 51(2):221-34. PubMed ID: 18259714
[TBL] [Abstract][Full Text] [Related]
7. Safety of reagents for infection testing: results of the market surveillance by the Federal Institute for Drugs and Medicinal Devices until end 2006.
Siekmeier R; Halbauer J; Mientus W; Wetzel D
J Physiol Pharmacol; 2008 Dec; 59 Suppl 6():629-43. PubMed ID: 19218690
[TBL] [Abstract][Full Text] [Related]
8. Implementing Regulation (EU) 2017/746 of 5 April 2017 on In vitro Diagnostic Medical Devices (IVDR) in Medical Laboratories, especially in Ophthalmopathology.
Auw-Hädrich C; Reinhard T; Hädrich J
Klin Monbl Augenheilkd; 2022 Jul; 239(7):905-912. PubMed ID: 35636459
[TBL] [Abstract][Full Text] [Related]
9. Home-brew tests need regulation.
Nature; 2014 Aug; 512(7512):5. PubMed ID: 25100448
[No Abstract] [Full Text] [Related]
10. Experience with post-market surveillance of in-vitro diagnostic medical devices for lay use in Germany.
Siekmeier R; Lütz J
Clin Chem Lab Med; 2007; 45(3):396-401. PubMed ID: 17378740
[TBL] [Abstract][Full Text] [Related]
11. [The network of official medicines control laboratories].
Buchheit KH; Wanko R
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2014 Oct; 57(10):1139-44. PubMed ID: 25192832
[TBL] [Abstract][Full Text] [Related]
12. IVD authorized representatives.
Donawa ME
Med Device Technol; 2003 May; 14(4):19-21. PubMed ID: 12774572
[TBL] [Abstract][Full Text] [Related]
13. Market surveillance of in vitro diagnostics by the BfArM until end 2010: how safe are products for tumor diagnostics?
Siekmeier R; Wetzel D
Adv Exp Med Biol; 2013; 755():385-96. PubMed ID: 22826091
[TBL] [Abstract][Full Text] [Related]
14. Market surveillance of in vitro diagnostics by the BfArM until end 2010: safety of IVD for therapeutic drug monitoring.
Siekmeier R; Wetzel D
Adv Exp Med Biol; 2013; 755():375-83. PubMed ID: 22826090
[TBL] [Abstract][Full Text] [Related]
15. [The implementation of European directives into national law, demonstrated by the example of the EC Tissues and Cells Directive 2004/23/EC].
von Auer F
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2008 Jul; 51(7):757-63. PubMed ID: 18563281
[TBL] [Abstract][Full Text] [Related]
16. Safety of laboratory analyzers for infection testing - results of the market surveillance by the BfArM until End 2007.
Siekmeier R; Halbauer J; Mientus W; Wetzel D
Eur J Med Res; 2009 Dec; 14 Suppl 4(Suppl 4):216-26. PubMed ID: 20156760
[TBL] [Abstract][Full Text] [Related]
17. Regulatory In Vitro Diagnostics Landscape in Africa: Update on Regional Activities.
McNerney R; Peeling RW
Clin Infect Dis; 2015 Oct; 61Suppl 3():S135-40. PubMed ID: 26409274
[TBL] [Abstract][Full Text] [Related]
18. [Official testing of immunological veterinary medicinal products].
Jungbäck C; Motitschke A
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2014 Oct; 57(10):1193-7. PubMed ID: 25168840
[TBL] [Abstract][Full Text] [Related]
19. Addressing US and European device testing requirements.
Donawa M
Med Device Technol; 2008 Sep; 19(5):32, 34-7. PubMed ID: 18947148
[TBL] [Abstract][Full Text] [Related]
20. Does customer information fulfill MEDDEV criteria in cases of product problems of in vitro diagnostics for infection testing?
Hannig J; Siekmeier R
Adv Exp Med Biol; 2015; 835():23-30. PubMed ID: 25310946
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
