Biological Evaluation Plan (BEP)

Preparation of a Biological Evaluation Plan (BEP): a comprehensive, risk-based document required by ISO 10993-1:2025 that identifies, justifies, and documents the approach for assessing the biological safety of a medical device or component. The BEP characterizes the nature, degree, frequency, and duration of patient contact; defines the intended clinical use; and specifies the biological endpoints to be evaluated. It presents a clearly defined evaluation strategy — applicable tests, literature-based justifications, rationales for testing exemptions, and recommendations for addressing identified biological risks — with traceability to the device's ISO 14971 risk management file, consistent with the lifecycle-based approach introduced in the 2025 revision. For devices with a gas pathway, the plan also covers ISO 18562-1:2024: worst-case patient group and breathing volume, contact duration, processing and aging, and justification for performing or waiving ISO 18562-2, -3 and -4 testing. Pricing Scope: - Base price covers evaluation of one (1) patient-contacting category (e.g., Externally Communicating – Tissue/Bone/Dentin, Limited Contact Duration ≤24 hours). - Literature search covering up to five (5) patient-contacting materials is included. - One (1) round of Client review and incorporation of consolidated comments is included. - Evaluation of additional patient-contacting categories beyond the initial category is billed separately, per category. Additional patient-contacting materials beyond the initial five (5) are billed separately, per material. - Further strategy development, specialized consulting, or advisory services requested by the Client are billed separately at the standard hourly rate. - Preparation of the Biological Evaluation Report (BER) is a separate deliverable and is not included in this scope. Expedited and After-Hours Work Urgent review or update requests, defined as any request for delivery in fewer than 3 business days from receipt, are billed at the standard hourly rate in addition to the base price. Any requirement for work to be performed outside standard business hours (Monday–Friday, 8:00 AM–5:00 PM ET, excluding observed holidays), including weekends and holidays, to meet a response deadline is billed at two times (2×) the standard hourly rate. Expedited requests are subject to resource availability and are confirmed in writing before work commences. All evaluations and strategies within the BEP are developed, reviewed, and approved by qualified biological safety specialists with documented competency in accordance with ISO 10993-1:2025. Estimated turnaround for initial draft: ten (10) business days from receipt of all required Client inputs.