Biological Evaluation Report (BER)

Preparation of a Biological Evaluation Report (BER) documenting and evaluating biocompatibility test results conducted according to a previously approved Biological Evaluation Plan (BEP). The report includes a comprehensive summary of all relevant biocompatibility testing outcomes, critical analysis of results against established biological safety endpoints, integration of relevant scientific literature or supplementary data, and clear conclusions regarding the biological safety and risk profile of the medical device/component. Where applicable, the report includes the gas pathway evaluation per ISO 18562-1:2024 and its supporting test and risk assessment data. Pricing and Additional Scope: - Base price covers detailed review, analysis, and documentation of biocompatibility test results as defined in the approved BEP. - Additional support activities beyond report authorship—such as regulatory meetings, consultations, responses to regulatory questions, or investigations into test anomalies and failures—are billed separately at the standard hourly rate. 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 reports are authored, reviewed, and approved by qualified biological safety specialists, in accordance with ISO 10993-1:2025 and regulatory requirements. Estimated turnaround time: two (2) weeks from receipt of all required Client inputs.