Understand the regulatory requirements of your in vitro test methods
4 Oct 2022
In this video, discover the Method Navigator from Clinical and Laboratory Standards Institute. Hear how the Method Navigator is designed to help test developers fulfill FDA, CLIA, ISO, and other requirements. Built off CLSI document EP19’s “Test Life Phase Model,” this product includes links to requirements, guidance tables and evidence tables, and fillable and downloadable checklists.
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Clinical and Laboratory Standards Institute
A not-for-profit membership organization, the Clinical and Laboratory Standards Institute (CLSI) brings together the global laboratory community for a common cause: fostering excellence in laboratory medicine. We do so by facilitating a unique process of developing clinical laboratory testing standards based on input from and consensus among industry, government, and health care professionals.
As an international organization, our members include 1,400+ organizations and 400+ individuals that come from over 60 countries. Through our unified efforts, we set and uphold the standards that drive quality test results, enhance patient care delivery, and improve public health around the world.
For nearly 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of medical laboratory testing standards. Standardization in the laboratory improves the quality and efficiency of testing, which ultimately improves patient care outcomes.
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Method Navigator
Clinical and Laboratory Standards InstituteMethod Navigator is an online subscription product that provides users with quick and easy access to specific guidance from CLSI documents. Method Navigator was designed to help test developers—whether they are test manufacturers or laboratories developing tests—fulfill FDA, CLIA, ISO, and other requirements.