Calibration services in the frame of accredited coagulation EQA schemes - Meeting the IVD directive

Research output: Contribution to journalArticle

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.

Details

Authors
  • Ulf Ornemark
  • Elisabeth Nilsson
  • Gunnar Nordin
  • Nils Egberg
  • Tomas L. Lindahl
  • Andreas Hillarp
  • Lennart Stigendahl
  • Inger Fagerberg
Organisations
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Medicinal Chemistry
  • Clinical Medicine

Keywords

  • assessment, external quality, in vitro diagnostic medical devices, calibration, coagulation
Original languageEnglish
Pages (from-to)451-454
JournalAccreditation and Quality Assurance
Volume11
Issue number8-9
Publication statusPublished - 2006
Publication categoryResearch
Peer-reviewedYes