ISO 10993-1:202501Biocompatibility Evaluation
Full biological safety assessment per ISO 10993-1:2025 for all device risk classes and patient contact types — from skin contact to long-term implants.
Explore serviceRegulatory Compliance
BEP / BER Preparation & Review
Regulator-ready Biological Evaluation Plans and Reports, written to be accepted the first time.
Overview
What is BEP / BER Preparation & Review?
The Biological Evaluation Plan (BEP) is your roadmap: it defines the device, its materials and categorisation, and the evidence required to demonstrate biological safety. The Biological Evaluation Report (BER) is the final scientific argument that the evidence supports safe use.
We prepare both documents end-to-end, or review and remediate documents you already have. Each is structured the way reviewers read them, with clear traceability from device description to endpoint, evidence and conclusion.
Our BEPs and BERs are written for EU MDR notified bodies, US FDA 510(k), De Novo and PMA submissions, CDSCO and other global authorities.
7 + 7Structured BEP & BER steps
AuditReady documentation
GlobalRegulator acceptance
When you need it
Typical triggers for this service
- Preparing a technical file or regulatory submission
- Responding to notified body or FDA questions on biocompatibility
- Upgrading legacy documentation to ISO 10993-1:2025
- Combining test data, chemistry and literature into one conclusion
- Independent review before an audit
What you receive
Deliverables
01Biological Evaluation Plan (BEP)
02Biological Evaluation Report (BER)
03Endpoint matrix with evidence traceability
04Test waiver and worst-case justifications
05Toxicological risk assessment summary
06Response support for regulator questions
Our approach
How we run the engagement
01
Kick-off & data collection
Device description, drawings, bill of materials, processing and existing reports.
02
Plan (BEP)
Categorisation, endpoint mapping, gap analysis and the testing strategy.
03
Evidence generation
Coordination of chemical characterisation and biological testing at accredited labs.
04
Report (BER)
Interpretation, toxicological risk assessment and the final safety conclusion.
05
Submission support
Responses to deficiency letters and notified body questions.
Standards & guidance
Aligned with
ISO 10993-1:2025ISO 10993-17:2023ISO 10993-18ISO 14971:2019EU MDR 2017/745FDA 510(k) / PMA / De Novo
FAQs
BEP / BER Preparation & Review: common questions
The BEP is written before testing and defines what evidence is needed and why. The BER is written after testing and characterisation, and concludes whether the evidence demonstrates biological safety for the intended use.
Yes. We regularly gap-assess and remediate third-party BERs, especially for EU MDR transition and ISO 10993-1:2025 updates.
It depends on device complexity and the data available. A plan for a simple device can be turned around quickly; complex implants with extensive chemistry take longer. We confirm a timeline after reviewing your documents.
Related services
Often combined with this service
ISO 10993-1:202501
TRA · PDE03Toxicological Risk Assessment
Science-based TRA with quantitative exposure estimates, toxicological thresholds, Margin of safety, and comprehensive conclusions per ISO 10993-18 and 10993-17.
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Multi-Market07Global Regulatory Compliance
FDA, OECD GLP, ISO 17025, NABL, EU MDR, CDSCO, Gulf & ASEAN regulatory alignment — one partner for all your target markets.
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Need bep / ber preparation & review for your device?
Talk to a DABT · ERT · UKRT certified toxicologist about your biological evaluation. Direct expert response within 2 hours.
Get In Touch
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