Performance Evaluation is a dynamic, lifecycle process critical for Medical Device Software (MDSW) under IVDR. Three key components should be taken into account when compiling clinical evidence for MDSW:
✅ Scientific Validity – Proving the association between the software’s outputs and the targeted clinical condition.
✅ Analytical Performance – Validating accurate and reliable outputs from input data.
✅ Clinical Performance – Demonstrating measurable, patient-relevant clinical outcomes.
🌍 At every step, clinical expertise is indispensable, from literature appraisal to interpreting results. This is where HaMaDa becomes your strategic partner, ensuring robust evidence, regulatory compliance, and project success. Let’s collaborate to navigate the complexities of IVDR together!
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