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Manufacturers of instrument systems for in vitro diagnostic use are closely regulated by the Food and Drug Administration and sell their products to clinical laboratories that participate in rigorous quality control and proficiency testing programs. In these circumstances, manufacturers must plan and implement procedures that will ensure acceptable accuracy and precision from all installed systems. This activity starts with the design goals and specifications and continues with manufacturing and quality assurance testing, through various postsale support services. This article outlines some specific instrumentation examples to demonstrate the accomplishment of these objectives. |
