Biological Risk Assessment / Safety Evaluation Plan (BA001)
NAMSA’s Biological Safety Evaluation Plans summarize and characterize a medical device based on the nature and duration of body contact, assesses the selection and materials of construction, reviews the manufacturing processes, identifies the minimum biological endpoints of concern, evaluates any existing research data available and then recommends and supports a testing strategy (plan) to address areas of remaining biological risk.
To complete the Biological Risk Assessment a NAMSA expert toxicologist will interpret and evaluate the data generated from testing or research recommended as part of the evaluation plan and complete the assessment to determine if all areas of biological risk, or relationship between the hazard and potential exposure (end-points) have been addressed. The assessment includes items such as predicate device review, biocompatibility testing rationale and results, chemical characterization interpretation, clinical data review, prior use and technical literature research information. That information is then harmonized into a final report tailored to your regulatory body requirements