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 |
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