Biological Evaluation Plan (BEP) : By considering the device materials, intended use, and existing data to prescribe a risk-based approach to the evaluation of device safety.

Biological Evaluation : Based on the risks identified in the BEP, perform a combination of analytical chemistry testing, biocompatibility testing and assessment, and toxicological risk assessment. Where ever possible, literature justification to be used as substitute. MakroCare contracts out all Lab related work but will oversee the full process (Vendor qualification to test review to reports validation)

Biological Evaluation Report (BER) : Interpret the BEP and the findings of the biological evaluation into one report. Written by expert assessors, this information is a summary of all the evidence gathered to support the biological safety of the device.