Consultation closed

Software as a Medical Device (SaMD): Application of Quality Management System

Start date
Closing date
Working group
Software as a Medical Device (SaMD)

A proposed document was released by the International Medical Device Regulators Forum (IMDRF) Software as a Medical Device Working Group.

Consultation documents

Software as a Medical Device (SaMD): Application of Quality Management System

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

World Health Organization (WHO)

Swissmedic

 

Affiliate members

SAHPRA - South African Health Products Regulatory Authority