Leveraging Device Clinical Data in Great Britain for IVDR Performance Evaluations
One of the challenges being experienced by IVD manufacturers, in meeting the requirements of the IVDR, is ensuring (and…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 46–54 of 79
IVDD vs IVDR: Greatest Impacts on IVD Manufacturers
The IVDR has brought about a paradigm shift in the regulatory framework for IVDs placed on the…
EU Device Regulatory Compliance: A Comprehensive Guide
While the focus of EU regulatory compliance for medical devices and…
PMPF Under the IVDR: Methods, Justifications, and Triggers
As we have mentioned in…
What is the Difference Between PMS and PMPF Under the IVDR?
While post-market clinical follow-up (PMCF) studies were a concept…
Linking IVDR Performance Evaluations and Risk Management
Similar to…
Performance Evaluation Reports Under the IVDR
The performance evaluation report (PER) is the culmination of the application of the performance evaluation process to a specific IVD…
Ensuring Compliance for Foreign Manufacturers of CE Marked ‘Legacy Devices’: Common Pitfalls and Solutions
As a regulatory representative for foreign manufacturers including those who are CE marked ‘legacy device’ in the EU, Switzerland and…
The Relevance of Device Stability Studies to IVDR Performance Evaluation
Under the IVDR, the performance evaluation report (PER) is supported by three “sub-reports” comprising the scientific validity report (SVR),…
Showing 46–54 of 79