Performance Evaluation Report for IVDR Compliance | i3CGlobal
A Performance Evaluation Report (PER) is a critical requirement under IVDR to prove that your in vitro diagnostic device is safe, clinically valid, and performs as intended. At i3CGlobal, the PER service is designed to simplify complex regulatory expectations by combining scientific rigor with practical regulatory expertise, helping manufacturers build strong, compliant documentation for EU market approval. From performance evaluation planning to clinical evidence assessment and final report preparation, their team supports you through every step, reducing delays, minimizing compliance risks, and improving the chances of successful CE marking under IVDR.
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