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Manufacturer's approach in transferring accuracy to multiple field installations
Archives of Pathology & Laboratory Medicine
|April 1, 1993
Summary
Instrument system manufacturers ensure accuracy and precision through rigorous design, manufacturing, and post-sale support. This process is vital for clinical laboratories using in vitro diagnostic devices.
Area of Science:
- Medical Device Manufacturing
- Clinical Laboratory Science
- In Vitro Diagnostics
Background:
- In vitro diagnostic (IVD) instrument systems are subject to stringent Food and Drug Administration (FDA) regulation.
- Clinical laboratories rely on these systems and adhere to strict quality control and proficiency testing.
Purpose of the Study:
- To outline the procedures manufacturers use to ensure accuracy and precision in IVD instrument systems.
- To demonstrate how manufacturers achieve reliable performance from design to post-sale support.
Main Methods:
- Manufacturers implement procedures starting from design goals and specifications.
- Quality assurance testing during manufacturing is crucial.
- Post-sale support services are integral to maintaining system performance.
Main Results:
- The described procedures ensure acceptable accuracy and precision for installed IVD systems.
- Specific instrumentation examples illustrate the successful implementation of these quality objectives.
Conclusions:
- A comprehensive approach encompassing design, manufacturing, and ongoing support is essential for IVD instrument reliability.
- Adherence to regulatory standards and quality control guarantees dependable diagnostic tools for clinical laboratories.
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