155 related articles for article (PubMed ID: 17924068)
1. [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]
2. [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]
3. 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]
4. 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]
5. 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]
6. 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]
7. Field safety notices released by manufacturers in cases of failure of products for infection testing: analysis of cases reported to the BfArM between 2005 and 2007.
Siekmeier R; Lisson K; Wetzel D
Eur J Med Res; 2010 Nov; 15 Suppl 2(Suppl 2):175-83. PubMed ID: 21147647
[TBL] [Abstract][Full Text] [Related]
8. [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]
9. [Are blood glucose analyzers safe? Experiences of the BfArM based on all notifications received until end of 2005].
Siekmeier R; Lütz J
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2006 Dec; 49(12):1212-8. PubMed ID: 17149661
[TBL] [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. Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.
Hannig J; Siekmeier R
Adv Exp Med Biol; 2015; 873():87-100. PubMed ID: 26453072
[TBL] [Abstract][Full Text] [Related]
12. 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]
13. Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.
Hannig J; Siekmeier R
Adv Exp Med Biol; 2015; 861():31-41. PubMed ID: 26047597
[TBL] [Abstract][Full Text] [Related]
14. [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]
15. [Experiences and recommendations of the German Federal Institute for Drugs and Medical Devices (BfArM) concerning clinical investigation of medical devices and the evaluation of serious adverse events (SAE)].
Renisch B; Lauer W
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2014 Dec; 57(12):1368-75. PubMed ID: 25376539
[TBL] [Abstract][Full Text] [Related]
16. [Scientific advice by the nationally competent authority and by the EMEA on the conduct of clinical trials].
Dejas-Eckertz P; Schäffner G
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Apr; 48(4):423-8. PubMed ID: 15830253
[TBL] [Abstract][Full Text] [Related]
17. IVD authorized representatives.
Donawa ME
Med Device Technol; 2003 May; 14(4):19-21. PubMed ID: 12774572
[TBL] [Abstract][Full Text] [Related]
18. [Medical devices. Regulatory framework and contribution of the German Federal Institute for Drugs and Medical Devices (BfArM) to the safe application].
Lauer W; Stößlein E; Brinker A; Broich K
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2014 Dec; 57(12):1355-61. PubMed ID: 25370170
[TBL] [Abstract][Full Text] [Related]
19. In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme.
Mbunkah HA; Reinhardt J; Kafere C; Scheiblauer H; Prat I; Nübling CM
Vox Sang; 2021 Jan; 116(1):3-12. PubMed ID: 32986873
[TBL] [Abstract][Full Text] [Related]
20. The IVD directive: late-phase practicalities.
Johnson P; Walker R
Med Device Technol; 2003 Nov; 14(9):35-6. PubMed ID: 14682022
[No Abstract] [Full Text] [Related]
[Next] [New Search]
