Reference Document

Document No. Description Date Document
AHWP/WG4/F001:2018 AHWP Post-Market Surveillance (PMS) Survey Report

8 Aug 2018

 AHWP Post-Market Surveillance (PMS) Survey Report.pdf
AHWP/WG1/F002:2016 Guidance for Minor Change Reporting

26 Nov 2016

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

26 Nov 2016

 Post Market Resource Center.pdf
AHWP/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
AHWP/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
AHWP/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
AHWP/WG1/R001:2012 The AHWP Technical Committee Working Group 1 Guidance on Mapping of STED to CSDT 7 July 2012 AHWP REFERENCE DOCUMENT_Mapping of CSDT to STED.pdf