Biological Evaluations are a systematic review to prove the safety of a product, taking into account the compatibility between the materials used and biological tissues, the chemical composition of the materials, including the conditions of exposure as well as the nature, degree, frequency and duration of exposure of the device to the patient.
Regulatory bodies are putting increased pressure on manufacturers for biological evaluations that deliver data linked together to demonstrate a comprehensive and clear assessment of risk. But the guidelines are broad and provide little actual direction.
Here are the challenges you face:
- Interpreting the guidelines is difficult.
- Developing a coordinated and thorough testing strategy demands knowledge and skill.
- Unexpected results will mean mid-stream revisions must be made to the test plan.
Creating a comprehensive data package for submission requires toxicological expertise.
Missing information causes delays and could even result in rejection.
Tests should be conducted with consideration of the information available from other sources, type of materials, and intended product use. Information gathered from chemical characterization testing is evaluated through risk assessment and serves as the impetus and justification of additional safety testing conducted.
All testing results, summary report of data, interpretations, and work should be incorporated together as the biological evaluation to prove the safety of your product.
Let our team of experts work with you to develop the appropriate test plan to achieve your goals. Our Biocompatibility Programs have a proven track record with global regulatory agencies.