BEP–BER Evidence Traceability Diagnostic
A Biological Evaluation Plan-to-Report diagnostic for checking whether planned biological questions remain linked to executed evidence, deviations, BER conclusions, risk management, and lifecycle controls.
Tool at a glance
12 Traceability Red Flags
Expose material breaks in identity, scope, evidence, test articles, deviations, conclusions, risk links, and lifecycle controls.
26 Control Checks
Reconcile controlled records, device facts, plan-to-report decisions, evidence provenance, and reopening triggers.
6 Priority Questions
Follow selected biological questions from the approved plan through evidence, disposition, conclusion, and risk linkage.
Find where the plan-to-report chain actually breaks
A Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) can each look polished while referring to different device states, evidence versions, test articles, assumptions, or biological questions. This diagnostic tests the links between them rather than scoring the documents in isolation.
Freeze the controlled baseline
Record the device, approved BEP, BER version and status, markets, contact facts, evidence cut-off, risk file, changes, and accountable reviewers.
Reconcile identity and scope
Challenge whether device configuration, materials, processing, sterilization, packaging, ageing, use, contact, population, and timing still align.
Follow the decision trace
Link each selected BEP question to the executed route, evidence locator, test article or bridge, deviation, disposition, BER conclusion, and risk record.
Preserve lifecycle trace
Check chemistry and TRA versions, contrary evidence, acceptance criteria, risk controls, changes, PMS signals, literature updates, and reopening triggers.
Respect qualified responsibility
The diagnostic does not author or approve a BEP or BER, decide evidence sufficiency, close deviations, or determine biological safety.
Use the ISO 10993-1:2025 BEP Builder to control planning work and the BER Evidence & Literature Evaluation Toolkit to structure report-stage evidence work. Choose BEP review, BER review, or a submission gap review according to the scope of the broken links.
Get Version 1.0
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Best For
- Teams reconciling an approved BEP with a draft or final BER
- Pre-submission and periodic biological-evaluation file review
- Remediation after device, evidence, chemistry, or risk-file changes
What Happens Next
- Download the eight-page interactive PDF
- Run the red flags, then trace six priority questions deeply
- Assign six actions from the most consequential broken links
Your next step will appear here.