Resources

WHO Medical Product Alert for falsified Uni-Gold HIV (No 2, 2020, version 2)

Author : WHO

Topic : Post-market surveillance

Type of document : WHO information notice for users

Document Category : Guidance for end-users

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WHO technical guidance series 7 - risk management for manufacturers of IVDs

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO prequalification performance evaluation protocols

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO overview of prequalification of IVDs assessment

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO guidance on post-market surveillance of IVDs

Author : WHO

Topic : Post-market surveillance

Type of document : Guidelines

Document Category : Guidance for end-users ,

WHO technical guidance series 2 - establishing stability of IVDs

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO maintenance manual for laboratory equipment, 2nd ed

Author : WHO

Topic : Maintenance

Type of document : Guidelines

Document Category : Guidance for end-users

WHO technical guidance series 6 - panels for quality assurance and quality control of IVDs

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO guidance on reportable changes to a WHO prequalified IVD

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

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