- by IMDRFHarmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.
- by IMDRFEnsure alignment of IMDRF QMS and risk management documents with current international standards
- by IMDRFSeeking to harmonize internationally, principles to help promote the development of safe and effective AI/ML enabled medical devices
- by IMDRFPromote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently.
- by IMDRFManage cybersecurity risks in medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements.