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.
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Expert Toxicology.Ensuring Safety.Enabling Compliance.
Smarter toxicology for better regulatory decisions — delivering comprehensive biological safety evaluation for medical devices worldwide, backed by 20+ years of expertise, global recognition, and regulator-compliance solutions.
Certified toxicologistsRecognised by FDA, EU MDR, UK & CDSCO reviewers
ISO 10993-1:2025 US FDA EU MDR 2017/745 CDSCO OECD GLP ISO 17025 NABL ISO 14971 ISO 18562-1:2024 ISO 7405:2025 Gulf & ASEAN
20+Years of toxicology
expertise
expertise
About BIOTOX by MedReg
Science-Led Safety for Every Device We Evaluate
Expert toxicology solutions for safe, compliant, successful products — smarter toxicology for better regulatory decisions, delivering comprehensive biological safety evaluation for medical devices worldwide.
- DABT, ERT & UKRT certified toxicologists
- Risk-based strategies that cut unnecessary testing
- One documentation strategy for FDA, EU MDR, CDSCO and beyond
DABTCertified toxicologist
I–IIIAll device types
10Specialist services
Core Services
Our Expertise
Smarter toxicology for better regulatory decisions — covering the full spectrum of biological safety for medical devices from concept to market approval.
ISO 10993-1:202501Regulatory 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.
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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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No Animal Testing04In-silico Safety Assessment
Computational toxicology tools for rapid, cost-effective chemical safety profiling without animal testing — fully aligned with regulatory expectations.
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E&L · Impurities05QSAR Analysis
Quantitative structure-activity relationship modelling for impurity and extractable & leachable safety profiling — reducing costly testing.
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Without Testing06Genotoxicity Prediction
QSAR-based genotoxicity prediction without animal testing — faster, more economical, and scientifically robust with full regulatory justification.
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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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ISO 1497108Risk Assessment & Management
Full ISO 14971 risk management file preparation integrated with your biological safety documentation — from hazard identification to residual risk.
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Active Devices09ISO 18562-1:2024 Compliance
We provide expert support for ISO 18562 compliance of breathing gas pathway medical devices, including biological evaluation planning, test strategy development, chemical characterization review and toxicological risk assessment.
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Dental · Oral10ISO 7405:2025 Compliance
Expert support for ISO 7405 compliance of dental materials and devices. Biological evaluation, toxicological risk assessment, and regulatory documentation. Helping manufacturers meet ISO 7405, ISO 10993, and global regulatory requirements.
Explore serviceHow We Work
From BEP to BER, One Clear Path
End-to-end biological safety compliance as per ISO 10993 & global regulations — from planning to final submission.
01
BEPPlan
Device categorisation, endpoint mapping and a risk-based test strategy.
02
E&L · TestingCharacterise
Chemical characterisation and only the biological tests that add information.
03
TRA · QSARAssess
Quantitative toxicological risk assessment of every constituent.
04
BERReport
A regulator-ready biological safety conclusion for your submission.
20+
Years of regulatory toxicology
10
Specialist services
9
Device categories covered
7+
Regulatory frameworks
Why Choose Us
Key Advantages of BIOTOX by MedReg
Expert guidance at every step — from first documentation to final submission worldwide.
Internationally Certified Experts
DABT, ERT & UKRT certified toxicologists — recognised for regulatory submissions in USA, UK, EU and other global regulatory authorities.
Faster Regulatory Approvals
Structured, audit-ready documentation significantly reduces regulatory queries and compresses your time to market across all major jurisdictions.
Minimises Testing Cost
Risk-based test waiver justifications eliminate unnecessary biological testing — saving significant budget without compromising scientific or regulatory compliance.
Multi-Market Compliance
EU MDR, US FDA, CDSCO, Gulf & ASEAN — one expert partner covering all your target regulatory markets with a single cohesive documentation strategy.
All Device Risk Classes
Full biocompatibility support for Class I, II, and III medical devices across all contact types, exposure durations, and clinical applications.
Large Expert Team
A multidisciplinary team delivering fast, reliable, and scalable toxicology and regulatory compliance services with the capacity to support global manufacturers.
Devices We Cover
Every Device Class. Every Contact Type.
From skin-contact wearables to long-term implants — biocompatibility support across all risk classes and clinical applications.
Class II · IIIOrthopaedic Implants
Bone, joint, spinal and fixation implant biocompatibility and regulatory compliance.
Class IIICardiovascular Devices
Stents, catheters, valves and critical cardiac device safety evaluation.
Class I · IIWearable & Homecare
Continuous-contact wearables and home monitoring device compliance.
IVD · Class IIDiagnostic & IVD
In-vitro diagnostic kits, reagents and diagnostic instrument evaluation.
Frequently Asked Questions
Answers to Key Regulatory & Toxicology Questions
Clear, authoritative insights into biocompatibility requirements, BEP/BER roadmaps, and non-animal testing strategies.
A BEP is a complete biocompatibility strategy that defines materials, device categorisation, and the biological testing required per ISO 10993-1:2025 — covering device description, material and chemical composition review, endpoint mapping, worst-case sample selection, test strategy, gap analysis, and risk-based testing recommendations.
A BER is the final biological safety assessment submitted to regulatory bodies after characterisation and testing are complete. It includes chemical characterisation interpretation, toxicological risk assessment, test results evaluation, justification for borderline results, risk mitigation, literature review, and the final safety conclusion for submission to FDA, EU MDR or CDSCO.
Yes. Our in-silico safety assessment and QSAR analysis provide computational toxicology and genotoxicity prediction without animal testing — faster, more economical, and scientifically robust with full regulatory justification.
We support Class I, II and III medical devices across all contact types and exposure durations, with multi-market compliance for FDA, OECD GLP, ISO 17025, NABL, EU MDR, CDSCO, and Gulf & ASEAN regulatory frameworks.
Through risk-based test waiver justifications that eliminate unnecessary biological testing while maintaining full scientific and regulatory compliance, backed by ISO 14971 risk management integration from the start of engagement.
Ready to make your device submission-ready?
Talk to a DABT · ERT · UKRT certified toxicologist about your biological evaluation. Direct expert response within 2 hours.
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Do You Have an Enquiry?
We are here to support your safety, compliance & success. Reach out to our certified toxicology experts today.
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