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
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Application of Risk Management to Medical Devices
Integration of a risk management system into your existing quality management system.
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Implementation of process validation system including IQ, OQ, and PQ qualifications.
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Establish and implement an effective tailored cGMP system in line with requirements.
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