Biological Evaluation Plan (BEP)/Report (BER)

What is a Biological Evaluation Plan and Report?

A Biological Evaluation Plan (BEP) and a Biological Evaluation Report (BER) are crucial components in the risk management process of medical devices.
The BEP plans the strategy for evaluating the biological safety of a medical device according to ISO 10993-1 and connects the biological evaluation with the overall risk analysis according to ISO 14971. It identifies the biological risks associated with the device and identifies the necessary biocompatibility test strategy based on available biocompatibility and toxicological data. The BER documents the results of the performed biocompatibility testing, interprets the collected toxicological data and concludes on the biological safety of the medical device.

AML Christensen’s service

At AML Christensen, we have a long-lasting experience in developing BEPs/BERs that comply with the requirements of ISO 10993-1 and ISO 14971. By meticulously planning and documenting the biological evaluation as part of your risk management process, we can help you ensure the safety and compliance of your medical devices, thereby protecting patient health and facilitating regulatory approval.

At AML Christensen, we can support you with our proven BEP/BER templates, which have been developed to ensure that all regulatory requirements are met. Or we can use your own templates, if so preferred.

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Biological Evaluation Plan (BEP)/Report (BER)

What is a Biological Evaluation Plan and Report?

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