IMDRF - Working Groups en Software as a 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 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 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 Personalized Medical Devices (PMD) 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 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 Good Regulatory Review Practices Develop good review practices for pre-market reviews and evaluations. Tue, 20 Jul 2021 09:45:07 +1000 IMDRF Regulated Product Submission Harmonize the format and content of regulatory submissions. Thu, 08 Jul 2021 09:55:56 +1000 IMDRF