The medical device industry plays a pivotal role in healthcare, ensuring access to essential devices while upholding stringent regulatory standards. […]
The MHRA have started a pilot project in response to a white paper published in 2023 by the UK government […]
We’re excited to share the latest update to the IMDRF’s labeling guidelines for medical devices and IVDs. The IMDRF/GRRP WG/N52 […]
There is a new IVDR MDCG guidance published MDCG 2024-4 Safety Reporting in performance studies of in vitro diagnostic medical […]
Swiss Medtech released a guidance document tailored for economic operators in Switzerland. It delineates the necessary steps for ensuring compliance […]
The Medical Device Coordination Group (MDCG) is active this month, releasing a new guidance document. This latest guidance focuses on […]
Changes to Swissmedic FSCA Report V2.3 Swissmedic has recently updated the Foreign Serious Incident Report (FSCA) template to version 2.3. […]
By 26 May 2024, manufacturers must have an MDR compliant Quality Management System in place and have lodged an application […]
The FDA has issued a final guidance on the sterilization of devices labeled as sterile. The guidance updates and clarifies […]
The Food and Drug Administration (FDA) has released a draft guidance proposing revisions to the “Cybersecurity in Medical Devices: Quality […]