A strategic, ISO 10993-aligned roadmap that defines exactly how the biological safety of your device will be demonstrated — before testing begins.
A Biological Evaluation Plan is the foundational document required under ISO 10993-1 that outlines the strategy for assessing your device's biocompatibility. It defines the nature of body contact (surface, external communicating, or implant), the duration of contact (limited, prolonged, or permanent), and the biological endpoints that need evaluation — cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and implantation effects.
The BEP serves as a roadmap that justifies which tests are necessary, which can be waived based on existing data or material equivalence, and how the overall biological safety of the device will be demonstrated to regulatory bodies such as the FDA and EU MDR notified bodies.
Surfacing existing data that can reduce or justify testing needs.
Identifying missing data against current regulatory expectations.
Mapping endpoints to your device's contact type and duration.
Structuring the plan to match your target market's expectations.
We review materials, manufacturing process, and intended patient contact.
Supplier data, prior submissions, and published literature are reviewed for reuse.
Every relevant biological endpoint is matched to a testing or rationale strategy.
A finalized, regulator-ready BEP is delivered with ongoing support as your program evolves.
A finalized BEP mapping every required biological endpoint to a testing or rationale strategy.
Clear identification of data gaps and recommended studies.
A defensible, ISO-aligned rationale ready for regulator review.
Direct access to the toxicologist who authored your plan for follow-up questions.
Talk to our regulatory and scientific experts today.
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