IVD Incident Reporting: Regulatory Standards for Manufacturers
In the complex world of medical device and IVD manufacturing, adherence…
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IVDR Clinical Performance Studies: Considerations for EU Approval
In other articles, we have covered considerations for manufacturers about clinical investigations when pursuing CE marking under the…
IVD Regulations Within the UK: A Comprehensive Overview
Understanding the evolving landscape of UK IVD regulations as a manufacturer can be difficult when wanting to ensure the correct…
EU IVDR Labeling: Requirements and Best Practices
The term “labeling” in the European in vitro diagnostic medical device Regulation 2017/746…
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…
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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