BEP + BER Solutions for Medical Devices
End-to-end biological safety compliance as per ISO 10993 & global regulations — from planning to final submission.
Biological Evaluation Plan
BEPYour roadmap for biological safety — a complete biocompatibility strategy defining materials, device categorisation, and required testing per ISO 10993-1:2025.
Device Description & Clinical Use Analysis
Characterisation of intended use, patient contact, exposure duration and device risk class.
Material & Chemical Composition Review
Review of all materials, coatings, adhesives and processing aids in patient contact zones.
ISO 10993-1:2025 Endpoint Mapping
Mapping of all required biological endpoints per the latest ISO 10993-1:2025 framework.
Risk-Based Worst-Case Sample Selection
Identification of worst-case materials and samples for targeted, efficient biological testing.
Biological Test Strategy & Waiver Justifications
Science-backed test waivers to reduce testing cost while maintaining full regulatory compliance.
Gap Analysis of Available Data
Systematic review of existing literature, manufacturer data, and historical safety records.
Risk-Based Testing Recommendations
Final prioritised testing plan with clear rationale and full regulatory alignment strategy.
A complete, audit-ready biological evaluation strategy that reduces testing costs and accelerates your path to regulatory compliance.
Biological Evaluation Report
BERRegulator-ready biological safety — the final biological safety assessment submitted to regulatory bodies after characterisation and testing is complete.
Material / Chemical Characterisation Interpretation
Interpretation of E&L data and chemical characterisation results from accredited laboratories.
Toxicological Risk Assessment (TRA)
Full quantitative TRA with exposure estimation, toxicological thresholds and safety margins.
Biological Testing Results Evaluation
Critical scientific review and interpretation of all biological test results from accredited labs.
Justification for Borderline / Failed Tests
Expert scientific rationale and contextual justification for out-of-specification results.
Mitigations for Residual Risks
Risk mitigation strategies, labelling recommendations and post-market surveillance inputs.
Literature Review & Clinical Background
Comprehensive scientific literature review supporting the biological safety conclusion.
Final Safety Conclusion for Intended Use
Definitive biological safety conclusion structured for direct submission to FDA, EU MDR or CDSCO.
Complete, regulator-ready BERs that satisfy notified body and worldwide regulatory requirements, ensuring a smooth submission process from the outset.
Start with a Biological Evaluation Plan
Talk to a DABT · ERT · UKRT certified toxicologist about your biological evaluation. Direct expert response within 2 hours.
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