Resources

Sample product dossier for a quantitative nucleic acid-based testing technology to measure HIV-1 RNA
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO risk based classification of diagnostics for WHO prequalification
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO technical guidance series 3 - principles of performance studies
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
Sample product dossier for a qualitative nucleic acid‑based testing technology for HIV-1 and HIV-2
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO risk based approach for the assessment of IVDs
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO technical guidance series 2 - establishing stability of IVDs ANNEX
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO technical guidance series 7 - risk management for manufacturers of IVDs 
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO prequalification performance evaluation protocols
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO overview of prequalification of IVDs assessment
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers