医疗器械单一审核计划 (MDSAP)
- IMDRF/MDSAP WG/N11FINAL:2014 MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization
- IMDRF/MDSAP WG/N24FINAL:2015 Medical Device Regulatory Audit Reports
- IMDRF/MDSAP WG/N3FINAL:2016 (Edition 2) Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition
- IMDRF/MDSAP WG/N4FINAL:2013 Competence and Training Requirements for Auditing Organizations
- IMDRF/MDSAP WG/N5 Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations
- IMDRF/MDSAP WG/N6FINAL:2013 Regulatory Authority Assessor Competence and Training Requirements
- IMDRF/MDSAP WG/N8 Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations