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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Smarter toxicology for better regulatory decisions — covering the full spectrum of biological safety for medical devices from concept to market approval.
ISO 10993-1:2025BEP / BERTRA · QSARISO 18562ISO 7405
ISO 10993-1:202501
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.
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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.
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