Expertise BEP + BER Why Us Devices Standards Enquire Now →
ISO 10993 · FDA · EU MDR · CDSCO

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.

DABT · ERT · UKRT Certified toxicologist
ISO 10993-1:2025
FDA · OECD GLP
EU MDR · NABL
20+ Years Expertise
ISO 18562-1:2024
ISO 7405:2025
20+
Years of Expertise
DABT
Certified Toxicologist
Class I–III
All Device Types
Get in Touch Our Process →
BIOTOX
by Medreg
Biocompatibility
BEP / BER
Risk Assessment
In-silico
QSAR · PDE
Core Services
Our Expertise
Smarter toxicology for better regulatory decisions — covering the full spectrum of biological safety for medical devices worldwide.
01ISO 10993-1:2025
Biocompatibility 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.
02Regulatory Compliance
BEP / BER Preparation & Review
End-to-end Biological Evaluation Plans and Reports — regulator-ready, audit-proof, and globally accepted by notified bodies and regulatory authorities.
03TRA · PDE
Toxicological Risk Assessment
Science-based TRA with quantitative exposure estimates, toxicological thresholds, Margin of safety, and comprehensive conclusions per ISO 10993-18 and 10993-17.
04No Animal Testing
In-silico Safety Assessment
Computational toxicology tools for rapid, cost-effective chemical safety profiling without animal testing — fully aligned with regulatory expectations.
05E&L · Impurities
QSAR Analysis
Quantitative structure-activity relationship modelling for impurity and extractable & leachable safety profiling — reducing costly testing.
06Without Testing
Genotoxicity Prediction
QSAR-based genotoxicity prediction without animal testing — faster, more economical, and scientifically robust with full regulatory justification.
07Multi-Market
Global Regulatory Compliance
FDA, OECD GLP, ISO 17025, NABL, EU MDR, CDSCO, Gulf & ASEAN regulatory alignment — one partner for all your target markets.
08ISO 14971
Risk Assessment & Management
Full ISO 14971 risk management file preparation integrated with your biological safety documentation — from hazard identification to residual risk.
09Active Devices
ISO 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
10Dental · Oral
ISO 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.
Our Process
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
BEP — Your Roadmap for Biological Safety
A complete biocompatibility strategy defining materials, device categorisation, and required testing per ISO 10993-1:2025.
01
Device Description & Clinical Use Analysis
Characterisation of intended use, patient contact, exposure duration and device risk class.
02
Material & Chemical Composition Review
Review of all materials, coatings, adhesives and processing aids in patient contact zones.
03
ISO 10993-1:2025 Endpoint Mapping
Mapping of all required biological endpoints per the latest ISO 10993-1:2025 framework.
04
Risk-Based Worst-Case Sample Selection
Identification of worst-case materials and samples for targeted, efficient biological testing.
05
Biological Test Strategy & Waiver Justifications
Science-backed test waivers to reduce testing cost while maintaining full regulatory compliance.
06
Gap Analysis of Available Data
Systematic review of existing literature, manufacturer data, and historical safety records.
07
Risk-Based Testing Recommendations
Final prioritised testing plan with clear rationale and full regulatory alignment strategy.
Key Outcome
A complete, audit-ready biological evaluation strategy that reduces testing costs and accelerates your path to regulatory compliance
Biological Evaluation Report
BER — Regulator-Ready Biological Safety
The final biological safety assessment submitted to regulatory bodies after characterisation and testing is complete.
01
Material / Chemical Characterisation Interpretation
Interpretation of E&L data and chemical characterisation results from accredited laboratories.
02
Toxicological Risk Assessment (TRA)
Full quantitative TRA with exposure estimation, toxicological thresholds and safety margins.
03
Biological Testing Results Evaluation
Critical scientific review and interpretation of all biological test results from accredited labs.
04
Justification for Borderline / Failed Tests
Expert scientific rationale and contextual justification for out-of-specification results.
05
Mitigations for Residual Risks
Risk mitigation strategies, labelling recommendations and post-market surveillance inputs.
06
Literature Review & Clinical Background
Comprehensive scientific literature review supporting the biological safety conclusion.
07
Final Safety Conclusion for Intended Use
Definitive biological safety conclusion structured for direct submission to FDA, EU MDR or CDSCO.
Deliverable
Complete, regulator-ready BERs that satisfy notified body and worldwide regulatory requirements, ensuring a smooth submission process from the outset.
Why Choose Us
Key
Advantages
of BIOTOX
by MedReg

Expert guidance at every step — from first documentation to final submission worldwide.

WHY
US
01
Internationally Certified Experts
DABT, ERT & UKRT certified toxicologists — recognised for regulatory submissions in USA, UK,EU and other global regulatory authorities.
02
Faster Regulatory Approvals
Structured, audit-ready documentation significantly reduces regulatory queries and compresses your time to market across all major jurisdictions.
03
Minimises Testing Cost
Risk-based test waiver justifications eliminate unnecessary biological testing — saving significant budget without compromising scientific or regulatory compliance.
04
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.
05
All Device Risk Classes
Full biocompatibility support for Class I, II, and III medical devices across all contact types, exposure durations, and clinical applications.
06
Large Expert Team
A multidisciplinary team delivering fast, reliable, and scalable toxicology and regulatory compliance services with the capacity to support global manufacturers.
Device Categories We Support
Medical Device Types We Cover
Biocompatibility and regulatory compliance support across all major medical device categories — from Class I to Class III.
Orthopaedic Implants
Bone, joint, spinal and fixation implant biocompatibility and regulatory compliance.
Class II · III
Cardiovascular Devices
Stents, catheters, valves and critical cardiac device safety evaluation.
Class III
Wearable & Homecare
Continuous-contact wearables and home monitoring device compliance.
Class I · II
Diagnostic & IVD
In-vitro diagnostic kits, reagents and diagnostic instrument evaluation.
IVD · Class II
Dental Devices
Implants, restorative materials and orthodontic device biocompatibility.
Class II · III
Wound Care & Dressings
Biocompatibility assessment for wound management and dressing products.
Class I · II
Catheters & Tubing
Cannulas, infusion sets, drainage tubes and fluid delivery system compliance.
Class II · III
Surgical Instruments
Reusable and single-use surgical device regulatory compliance support.
Class I · II
Respiratory & Gas Pathway
Inhalation devices, nebulizers, oxygen delivery systems and respiratory tract biocompatibility assessment.
Class I · II
Standards & Accreditations
Globally Recognised Standards We Work With
Our work aligns with the most rigorous international regulatory frameworks — ensuring your documentation is accepted worldwide without rework.
FDA
U.S. Food & Drug Administration
510(k), PMA & De Novo submission support
OECD GLP
OECD Good Laboratory Practice
GLP-compliant study design & documentation
ISO 10993
Biological Evaluation of Medical Devices
Full series including ISO 10993-1:2025 updates
ISO 17025
Testing & Calibration Laboratories
Accredited laboratory selection & data review
NABL
National Accreditation Board for Labs
India-specific accredited laboratory network
EU MDR
EU Medical Device Regulation 2017/745
CE marking biological safety documentation
20+
Years Regulatory Experience
Class I · II · III
All Device Risk Classes Supported
Zero Rework Commitment
Every deliverable is structured for notified body review, FDA inspection, and internal quality audits — approved first time, every time.
ISO 14971 Risk Management
Full risk management file preparation integrated with your biological safety documentation from the very first day of engagement.
Get In Touch

Do You Have
an Enquiry?

We are here to support your safety, compliance & success.
Reach out to our certified toxicology experts today.

Email Us
enquiry@medregbiotox.com
Call Us
+91 88664 61989
Call Us
+91 94094 06215
Website
www.medreg.in
Let's Decode The Regulations Together
Expert Toxicology Solutions for Safe · Compliant · Successful Products