APEC Regulatory Harmonization Steering Committee (RHSC)
Results
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.
Consultation
Standalone Software: Key Definitions, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Friday, 30 August 2013.
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.
Consultation
Medical Device Software: Considerations for Device and Risk Characterization, Software as a Medical Device Closes 2 May 2024