Working groups
![adverse-event-terminology](/sites/default/files/styles/imdrf_thumbnail/public/2021-09/adverse-event-terminology.jpg?itok=60uIs5ro)
Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.
![artificial-intelligence-medical-devices](/sites/default/files/styles/imdrf_thumbnail/public/2021-09/artificial-intelligence-medical-devices.jpg?itok=fNRQYhEp)
Seeking to harmonize internationally, principles to help promote the development of safe and effective AI/ML enabled medical devices
![good-regulatory-review-practices](/sites/default/files/styles/imdrf_thumbnail/public/2021-09/good-regulatory-review-practices.jpg?itok=u87APt6L)
Develop good review practices for pre-market reviews and evaluations.
![personalized-medical-device](/sites/default/files/styles/imdrf_thumbnail/public/2021-09/personalized-medical-device.jpg?itok=vE04HLMl)
Harmonize the regulatory requirements for medical devices that are intended for a particular individual, considering unique characteristics and risks associated with each type of device.
Ensure alignment of IMDRF QMS and risk management documents with current international standards
![regulated-product-submission](/sites/default/files/styles/imdrf_thumbnail/public/2021-09/regulated-product-submission.jpg?itok=hJO6mYmC)
Harmonize the format and content of regulatory submissions.
![Doctor holding AI Slide on Virtual Screen](/sites/default/files/styles/imdrf_thumbnail/public/2022-06/SAMD%20New%20WG%20Image.jpg?itok=JXj4kAR6)
Promote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently.