Technical document 2 October 2015 Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations
Information document 7 April 2015 Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects – Good clinical practice"
Information document 21 November 2014 Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014
Technical document 18 September 2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
Information document 18 September 2014 MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes
Information document 30 June 2014 Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS
Technical document 18 December 2013 UDI Guidance: Unique Device Identification (UDI) of Medical Devices