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 serviceISO 14971
Risk Assessment & Management
Biological risk fully integrated into your ISO 14971 risk management file.
Overview
What is Risk Assessment & Management?
ISO 10993-1:2025 positions biological evaluation firmly within the ISO 14971 risk management process. Regulators now expect to see a clear link between biological hazards, their risk controls and the overall benefit–risk conclusion.
We prepare and update risk management files that connect material characterisation, toxicological evaluation and clinical use, from hazard identification through to the evaluation of residual risk.
Biological risk then becomes part of a single, consistent risk story across your technical documentation.
1Integrated risk story
FullHazard-to-residual traceability
AuditReady file
When you need it
Typical triggers for this service
- Building a risk management file for a new device
- Aligning biological evaluation with ISO 14971
- Notified body findings on risk management
- Design, material or process changes
- Post-market surveillance updates
What you receive
Deliverables
01Risk management plan
02Biological hazard identification
03Risk analysis and evaluation
04Risk control measures and verification
05Residual risk and benefit–risk evaluation
06Risk management report
Our approach
How we run the engagement
01
Plan
Scope, risk acceptability criteria and responsibilities.
02
Hazard identification
Biological, chemical and use-related hazards.
03
Risk analysis
Estimation of probability and severity for each hazardous situation.
04
Risk control
Control measures, verification and labelling recommendations.
05
Residual risk
Overall residual risk and benefit–risk conclusion.
Standards & guidance
Aligned with
ISO 14971:2019ISO/TR 24971ISO 10993-1:2025EU MDR Annex IFDA QMSR
FAQs
Risk Assessment & Management: common questions
ISO 10993-1:2025 requires the biological evaluation to be carried out within a risk management process, so regulators expect clear traceability between the two.
We can prepare the full file or integrate biological risk into the file you already maintain.
Whenever the device, its materials, processes or post-market data change in a way that could affect risk.
Related services
Often combined with this service
ISO 10993-1:202501
Multi-Market07Global Regulatory Compliance
FDA, OECD GLP, ISO 17025, NABL, EU MDR, CDSCO, Gulf & ASEAN regulatory alignment — one partner for all your target markets.
Explore service
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 service
Need risk assessment & management 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.