APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Consultation
MDSAP - Guidance on Regulatory Authority Assessment Methods of Auditing Organization's Processes, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman MSc, Closed 1 June 2015.
Consultation
MDSAP - Medical Device Regulatory Audit Reports, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman MSc, Closed 1 June 2015.
Consultation
MDSAP Assessment Outcomes and Recognition/Re-recognition Decision by Regulatory Authorities, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Saturday, 31 May 2014.
Consultation
Assessor competency and training requirements for Regulatory Authorities undertaking assessments of auditing organizations, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Friday, 30 August 2013.
Consultation
Regulatory Assessment Program and Assessment Strategy utilizing for the recognition and monitoring of medical device auditing organizations, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Friday, 30 August 2013.
Consultation
Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Friday, 14 June 2013.
Consultation
Recognition and monitoring of organizations undertaking audits of medical device manufacturers, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Friday, 14 June 2013.
Consultation
Recognition Criteria for Medical Device Auditing Organizations, Medical device single audit program (MDSAP) Working Group, Coordinator Kimberly Trautman - US Food and Drug Administration (FDA), Closed Friday, 14 December 2012.
Consultation
Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form, A review of the NCAR system Working Group, Coordinator Jean-Francois Roche
European Commission, Closed Monday, 8 December 2014.
Consultation
Tools for Assessing the Usability of Registries in Support of Regulatory Decision Making, Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking Working Group, Coordinator Danica Marinac-Dabic, Closed 1 December 2017.