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
Post-Market Surveillance and Vigilance
Establishment and implementation of PMS to review experience gained from devices in the post-production phase.
+ Learn MoreGood Manufacturing Practice (cGMP)
Establish and implement an effective tailored cGMP system in line with requirements.
+ Learn MoreProcess Validation Including Software
Implementation of process validation system including IQ, OQ, and PQ qualifications.
+ Learn More