IMDRF - Working Groups https://www.imdrf.org/ en Software as a Medical Device https://www.imdrf.org/working-groups/software-medical-device Promote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently. Tue, 28 Jun 2022 10:47:55 +1000 IMDRF https://www.imdrf.org/working-groups/software-medical-device Clinical Evidence for IVD Medical Devices https://www.imdrf.org/working-groups/clinical-evidence-ivd-medical-devices A newly established working group Tue, 01 Feb 2022 16:45:34 +1100 IMDRF https://www.imdrf.org/working-groups/clinical-evidence-ivd-medical-devices Artificial Intelligence Medical Devices https://www.imdrf.org/working-groups/artificial-intelligence-medical-devices Develop an aligned approach to the management of artificial intelligence based medical devices. Wed, 28 Jul 2021 08:42:22 +1000 IMDRF https://www.imdrf.org/working-groups/artificial-intelligence-medical-devices Medical Device Cybersecurity Guide https://www.imdrf.org/working-groups/medical-device-cybersecurity-guide Manage cybersecurity risks in medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements. Mon, 26 Jul 2021 17:11:29 +1000 IMDRF https://www.imdrf.org/working-groups/medical-device-cybersecurity-guide Personalized Medical Devices (PMD) https://www.imdrf.org/working-groups/personalized-medical-devices 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. Thu, 22 Jul 2021 17:22:09 +1000 IMDRF https://www.imdrf.org/working-groups/personalized-medical-devices Adverse Event Terminology https://www.imdrf.org/working-groups/adverse-event-terminology Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection. Wed, 21 Jul 2021 09:24:14 +1000 IMDRF https://www.imdrf.org/working-groups/adverse-event-terminology Good Regulatory Review Practices https://www.imdrf.org/working-groups/good-regulatory-review-practices Develop good review practices for pre-market reviews and evaluations. Tue, 20 Jul 2021 09:45:07 +1000 IMDRF https://www.imdrf.org/working-groups/good-regulatory-review-practices Regulated Product Submission https://www.imdrf.org/working-groups/regulated-product-submission Harmonize the format and content of regulatory submissions. Thu, 08 Jul 2021 09:55:56 +1000 IMDRF https://www.imdrf.org/working-groups/regulated-product-submission