Optimizing Your Performance Evaluation Report (PER) for IVDR
The European Union’s In Vitro Diagnostic Regulation (IVDR) presents a rigorous regulatory framework that demands high standards of clinical evidence, making the Performance Evaluation Report (PER) a critical document for […]
Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024
The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD […]
[FREE WHITE PAPER] Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness
Overview This white paper is a companion piece to our popular webinar where we break down the steps of the systematic literature review (SLR) process and take a wholistic approach […]