APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Technical document
IMDRF/SaMD WG/N12
Technical document: IMDRF/SaMD WG/N12FINAL:2014
Published date
Technical document
IMDRF/SaMD WG/N10
Technical document: IMDRF/SaMD WG/N10FINAL:2013
Published date
Working group
Develop international definitions, risk category framework, and quality management system.
Consultation
Software as a Medical Device (SaMD): Clinical Evaluation, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel, Closed 13 December 2016.
Consultation
Software as a Medical Device (SaMD): Application of Quality Management System, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel, Closed 01 June 2015.
Consultation
Software as a Medical Device (SaMD): online survey now open, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Monday, 3 August 2015.
Page
Closed consultations of the International Medical Device Regulators Forum (IMDRF) or its working groups.
Working group
Promote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently.
Page
International Medical Device Regulators Forum (IMDRF) closed working groups that have completed work tasks requested by the IMDRF Management Committee.
Consultation
Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Saturday, 31 May 2014.