Calibration services in the frame of accredited coagulation EQA schemes - Meeting the IVD directive
Research output: Contribution to journal › Article
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.
|Research areas and keywords||
Subject classification (UKÄ) – MANDATORY
|Journal||Accreditation and Quality Assurance|
|Publication status||Published - 2006|