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20 documents en 1 page
 
 
 
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A Guide to Aid the Selection of Diagnostic Tests. (Bull World Health Organ 2017;95:639–645)

An:

2017;

Pages:

7;


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Instructions for compilation of a product dossier - Prequalification of In Vitro Diagnostics Programme

An:

2014;

Pages:

37;


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Instructions for the completion of the pre-submission form - Prequalification of In Vitro Diagnostics

An:

2017;

Pages:

10;


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Overview of the WHO Prequalification of in Vitro Diagnostics Assessment. Version 8. Geneva: World Health Organization; 2018 - WHO Prequalification of in Vitro Diagnostics

An:

2018;

Pages:

28;


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Product dossier checklist - Prequalification of In Vitro Diagnostics Programme

An:

2014;

Pages:

13;


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Technical Guidance Series 1 (TGS–1) for WHO Prequalification of in Vitro Diagnostic Medical Devices: Standards Applicable to the WHO Prequalification of in Vitro Diagnostic Medical Devices

An:

2017;

Pages:

33;


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Technical Guidance Series 2 (Annex to TGS–2) for WHO Prequalification – Diagnostic Assessment: Establishing Component Stability of In Vitro Diagnostic Medical Devices

An:

2019;

Pages:

24;


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Technical Guidance Series 2 (TGS–2) for WHO Prequalification – Diagnostic Assessment: Establishing stability of in vitro diagnostic medical devices. WHO Expert Committee on Biological Standardization, Sixty-eighth Report; WHO Technical Report Series No. 1011, 2018, Annex 5

An:

2018;

Pages:

61;


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Technical Guidance Series 3 (TGS–3) for WHO Prequalification – Diagnostic Assessment: Principles of Performance Studies

An:

2017;

Pages:

29;


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Technical Guidance Series 4 (TGS–4) for WHO Prequalification – Diagnostic Assessment: Guidance on Test Method Validation for in Vitro Diagnostic Medical Devices

An:

2017;

Pages:

26;


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Technical Guidance Series 5 (TGS–5) for WHO Prequalification – Diagnostic Assessment: Designing Instructions for Use for in Vitro Diagnostic Medical Devices

An:

2017;

Pages:

37;


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Technical Guidance Series 6 (TGS-6) for WHO Prequalification – Diagnostic Assessment: Panels for Quality Assurance and Quality Control of in Vitro Diagnostic Medical Devices

An:

2017;

Pages:

57;


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Technical Guidance Series 7 (TGS-7) for WHO Prequalification - Diagnostic Assessment: Risk Management for Manufacturers of in Vitro Diagnostic Medical Devices

An:

2018;

Pages:

66;


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Technical Guidance Series 8 (TGS-8) for WHO Prequalification – Diagnostic Assessment: Quality Control for In Vitro Diagnostic Medical Devices for WHO Prequalification. (Draft for Comment 9 April 2019)

An:

2019;

Pages:

40;


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