Clinical Evidence IVDR | MDV-Solve
Clinical Evidence for IVDs
Under IVDR, clinical evidence requirements for in vitro diagnostic devices have increased significantly.
Our expertise:
- Scientific validity
- Analytical performance
- Clinical performance
- Performance Evaluation Report (PER)
- PMPF planning
Related Services
Design Control Under EN ISO 13485 & 21 CFR PART 820
Establish and implement a system for design controls for various classes of medical devices.
+ Learn MoreThe New EU IVD Regulation (IVDR)
The In Vitro Diagnostic Regulation stipulates all requirements IVD manufacturers must comply with.
+ Learn MoreApplication of Risk Management to Medical Devices
Integration of a risk management system into your existing quality management system.
+ Learn More