Biological Evaluation Plan & Risk Assessment

What is a Biological Evaluation Plan?

A Biological Evaluation Plan is a key step in the regulatory pathway for a medical product. The Biological Evaluation Plan outlines the work plan for the required tests according to ISO 10993-1 based on the clinical use and patient contact conditions.

In preparing a Biological Evaluation Plan (BEP), Cambridge Polymer Group specialists examine the medical product’s composition, manufacturing process, design, packaging and intended clinical use, packaging, and supporting information that the client may have regarding clinical history or existing testing results. This information is used to prepare a set of tests that is both compliant with ISO 10993-1 and is specific to the medical product in question.

In addition to FDA regulatory filings, Cambridge Polymer Group’s biocompatibility specialists can assist with MDR remediation requests. Our scientists are experienced in identifying essential tests, minimizing costs and delays. A plan can be put into place for new devices, existing devices needing updates, or those undergoing material or process changes.

We work with your existing regulatory or development team to provide a third party and qualified expert opinion to assemble the BEP and can assist you in finding the appropriate vendors to conduct the biocompatibility testing. The execution of the BEP results in a Biological Evaluation Report (BER).

Biological Evaluation Report - Biological Risk Assessment

This report assesses your device's biological safety using a risk-based approach outlined in ISO 10993-1:2018. We consider physical and chemical information, biological testing results, and existing data to create a robust safety profile.

Following ISO 14971:2019 Clause 5.5, we incorporate various data sources: published research, scientific data, clinical evidence, and expert opinion. This ensures a comprehensive and defensible risk assessment.

The BER becomes a vital component of your regulatory submission, paving the way for a smooth approval process.

  • ISO 10993-1:2018 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
  • ISO 14971:2019 Medical devices-Application of risk management to medical devices

Contact CPG

Partner with Cambridge Polymer Group for your BEP/BER/BRA needs. Email or call us at 617-629-4400.