Information document 2 October 2015 Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk management to medical devices"
Information document 2 October 2015 Statement regarding Use of IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance"
Technical document 2 October 2015 Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations
Information document 2 October 2015 Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Information document 2 October 2015 Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices"
Information document 2 October 2015 Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR) Pilot Plan; Implementing Material
Information document 2 October 2015 Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan
Technical document 2 October 2015 Software as a Medical Device (SaMD): Application of Quality Management System