Bringing an IVD device to market requires clear evidence of scientific validity, analytical performance, and clinical performance. At DeSia, we help you prepare performance evaluation documents that meet international regulatory standards.
What We Offer
- Evaluation of safety and performance supported by clinical performance data
- Comparative analysis with similar IVD devices
- Systematic literature review and evidence gathering
- Determination of scientific validity, analytical performance, and clinical performance requirements
- Preparation of structured and detailed performance evaluation plans and reports
- Integration with risk management and product documentation.
We ensure that your documentation remains aligned with current regulations and supports your IVD device throughout its entire lifecycle.
Do you need help with your performance evaluation? Book your complimentary initial consultation.