Method Navigator
Method 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.

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Method 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. Built off of CLSI document EP19’s “Test Life Phase Model,” this product includes links to requirements, guidance tables and evidence tables, and fillable and downloadable checklists.
Understand the regulatory requirements of your in vitro test methods
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.



















