The consolidated scientific report that brings together all biological safety data and analysis into the document regulators expect to review.
A Biological Evaluation Report (BER) brings together every piece of biological safety evidence for your device — test data, chemical characterization results, toxicological risk assessments, and literature review findings — into the single report regulators review to confirm biocompatibility.
The BER integrates the BEP's planned approach with the actual outcomes, provides a rationale for the overall safety conclusion, and forms a key part of the technical documentation submitted to regulatory authorities — including FDA 510(k)/PMA submissions and EU MDR Technical Files.
Incorporating relevant published data into the evidence base.
Folding extractables/leachables data into the biocompatibility narrative.
Aligning risk assessment conclusions with each biological endpoint.
Formatting and structuring the report for your target regulator.
We collect test data, CC results, TRA conclusions, and literature findings against your BEP.
Each biological endpoint is evaluated against the available evidence.
Findings are compiled into a single, traceable biocompatibility conclusion.
The report passes internal scientific review before it reaches you.
A complete, regulator-ready Biological Evaluation Report.
Endpoint-by-endpoint biocompatibility conclusions.
Full traceability between data and conclusions.
Direct access to the authoring toxicologist for regulator follow-up.
Talk to our regulatory and scientific experts today.
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