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Calibration services in the frame of accredited coagulation EQA schemes – Meeting the IVD directive |
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| Authors: | Ulf Örnemark Elisabeth Nilsson Gunnar Nordin Nils Egberg Tomas L Lindahl Andreas Hillarp Lennart Stigendahl Inger Fagerberg |
| Institution: | 1. EQUALIS, Box 977, SE-751 09, Uppsala, Sweden 2. EQUALIS' expert group for coagulation, Uppsala, Sweden 3. Karolinska University Hospital, Solna, SE-171 76, Stockholm, Sweden 4. Link?ping University Hospital, SE-581 85, Link?ping, Sweden 5. Malm? University Hospital, SE-205 02, Malm?, Sweden 6. Sahlgrenska University Hospital, SE-413 45, Gothenburg, Sweden |
| Abstract: | Organisers of external quality assurance programmes may, for various reasons, also manufacture in vitro diagnostic medical devices, or provide calibration services. This paper describes measures taken by a Swedish organiser to meet the requirements of the European Commission's directive 98/79/EC for a national calibration of prothrombin time. Quality management system requirements and interactions with coagulation experts are summarised.Presented at the Eurachem PT Workshop September 2005, Portorož, Slovenia |
| Keywords: | In vitro diagnostic medical devices Calibration External quality assessment Coagulation |
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