Reference Document

Submitted by admin on Thu, 08/09/2012 - 12:25
Document No. Description Date Document
GHWP/WG4/F001:2018 GHWP Post-Market Surveillance (PMS) Survey Report 2017

8 Aug 2018

??GHWP Post-Market Surveillance-PMS-Survey Report 2017.pdf
GHWP/WG1/F002:2016 Guidance for Minor Change Reporting

26 Nov 2016

??Guidance for Minor Change Reporting.pdf
GHWP/WG4/F002:2016 Post Market Resource Center

26 Nov 2016

?Post Market Resource Center.pdf
GHWP/WG1/F001:2014 White Paper on Medical Device Software Regulation - Software Qualification and Classification

21 Nov 2014

??Medical Device Software Qualification and Classification White Paper - FINAL DOCUMENT.pdf
GHWP/WG2/F001:2014

Comparison between the Common Submission Dossier Template (CSDT) format for In Vitro Diagnostic Medical Devices and the GHTF Summary Technical Documentation (STED) formats for In Vitro Diagnostic Medical Devices

21 Nov 2014 ?Comparison between CSDT and STED_IVDDs_Final.pdf
GHWP/WG2-WG8/F002:2014 Role of Standards in the Assessment of Medical Devices 21 Nov 2014 ?Role of Standards in the Assessment of Medical Devices_Final.pdf
GHWP/WG1/R001:2012 The GHWP Technical Committee Working Group 1 Guidance on Mapping of STED to CSDT 7 July 2012 ? GHWP REFERENCE DOCUMENT_Mapping of CSDT to STED.pdf