Resources

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
WHO technical guidance series 2 - establishing stability of IVDs
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO technical guidance series 6 - panels for quality assurance and quality control of IVDs
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers
WHO guidance on reportable changes to a WHO prequalified IVD
Author : WHO
Type of document : Guidelines
Document Category : Guidance for manufacturers