Regulatory Compliance02BEP / BER Preparation & Review
End-to-end Biological Evaluation Plans and Reports — regulator-ready, audit-proof, and globally accepted by notified bodies and regulatory authorities.
Explore serviceISO 10993-1:2025
Biocompatibility Evaluation
A complete, risk-based biological safety assessment for every device class and contact type.
Overview
What is Biocompatibility Evaluation?
Every medical device that touches a patient or user must be shown to be biologically safe. ISO 10993-1:2025 makes that evaluation a risk management activity, carried out within the framework of ISO 14971, rather than a checklist of tests.
Our certified toxicologists categorise your device by nature and duration of contact, map the biological endpoints that apply, and decide where existing data, chemical characterisation or literature can answer a question before any new testing is commissioned.
The result is a defensible biological safety case that notified bodies, the US FDA and CDSCO can follow from first principles, from skin-contact accessories to long-term implants.
I–IIIAll device risk classes
100%Endpoints addressed
↓Fewer unnecessary tests
When you need it
Typical triggers for this service
- New device development or a first regulatory submission
- Change of material, supplier, colourant, sterilisation or manufacturing process
- EU MDR transition and technical documentation remediation
- Notified body or FDA deficiency letters on biological safety
- Periodic re-evaluation under your post-market surveillance plan
What you receive
Deliverables
01Device categorisation by contact type and exposure duration
02Biological endpoint matrix per ISO 10993-1:2025
03Material and process review of all patient-contacting components
04Test strategy with scientific waiver justifications
05Laboratory selection support and protocol review
06Biological safety conclusion for your technical file
Our approach
How we run the engagement
01
Device & clinical use review
Intended use, patient population, contact type, duration and foreseeable misuse.
02
Material & chemical review
Formulations, additives, processing aids and residues in every patient-contacting part.
03
Endpoint mapping
Each biological endpoint assessed against existing evidence and identified data gaps.
04
Targeted testing
Only the tests that add information, run at accredited ISO 17025 and GLP laboratories.
05
Safety conclusion
An integrated conclusion that ties every endpoint back to the risk management file.
Standards & guidance
Aligned with
ISO 10993-1:2025ISO 10993-5 / -10 / -23ISO 10993-18ISO 14971:2019FDA ISO 10993-1 guidanceEU MDR Annex I
FAQs
Biocompatibility Evaluation: common questions
The 2025 revision ties the biological evaluation more closely to ISO 14971 risk management, clarifies how exposure duration is counted for repeated or intermittent use, and expects reasonably foreseeable misuse to be considered. Existing evaluations should be gap-assessed against the new edition.
No. Many endpoints can be addressed through chemical characterisation, toxicological risk assessment, literature and equivalence to marketed materials. We justify waivers scientifically so that testing is only performed where it adds information.
Yes. We review existing reports for relevance and quality, identify any gaps for the current standard, and build them into the overall evaluation.
Related services
Often combined with this service
Regulatory Compliance02
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.
Explore service
ISO 1497108Risk Assessment & Management
Full ISO 14971 risk management file preparation integrated with your biological safety documentation — from hazard identification to residual risk.
Explore service
Need biocompatibility evaluation for your device?
Talk to a DABT · ERT · UKRT certified toxicologist about your biological evaluation. Direct expert response within 2 hours.
Get In Touch
Do You Have an Enquiry?
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Tell us about your device
Share a few details and a certified toxicologist will get back to you, usually within 2 hours on business days.