Standardizing Adverse Event Reporting: IMDRF Terminology
Despite having been published over three years ago, many manufacturers marketing their devices in IMDRF within the…
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Trend Reporting Under the IVDR: Device Performance Issues
One of several changes introduced in the transition from the In…
EUDAMED User Guide: SSCPs and Certificates
The European Commission published the updated EUDAMED User Guide – Notified Bodies & Certificates…
MHRA Guidance on SaMDs: Navigating the Regulatory Landscape
Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes…
The Role of Regulatory Affairs in Product Development
In the complex and highly regulated world of medical…
MHRA Update Regarding Adverse Incidents Reporting
As of August 31, 2023, there are changes to how adverse incidents involving medical devices should be reported to…
New Swissmedic Swissdamed Medical Device Registration
Due to the status of the agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the…
Medical Device Stand-Alone Software Under the UK MHRA
Following a trend…
An Approach to PMS and PMCF for SaMD Startups
Medical Device Software (MDSW) (“Software”) developed by Medical Device (SaMD) startups, plays an important role…
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