Biological Evaluation  Report

Biological Evaluation Report

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The Biological Evaluation Report is a collective summary of material and chemical characterization of the medical devices, Toxicological risk assessments, biocompatibility tests performed and justifications for waving off the tests. The report includes all the supporting data from the material supplier, analysis reports, biological test reports, literature assessment of data, gap analysis and the rationale for why additional information isn’t needed. The report should include a statement confirming the biological risk analysis and completion of risk controls. The Biological Evaluation Report is used to demonstrate that a medical device will not pose any potential risks to patients or that the health benefit from the medical device is much greater than the risk posed by it during its clinical intended use.