I3CGlobal provides complete biological evaluation support to help manufacturers meet ISO 10993 requirements with clarity and precision. Their team prepares detailed Biological Evaluation Reports (BER) based on risk management, material analysis, and clinical data. With a strong regulatory background, I3CGlobal ensures your evaluation aligns with MDR, IVDR, and FDA expectations. Their streamlined approach helps reduce compliance issues, avoid testing gaps, and ensure product safety while accelerating successful regulatory submissions in global markets.

biological evaluation