Toxicological risk assessment and biological safety documentation aligned with ISO 10993, EU MDR, and IVDR requirements.
Bioexcel Provides Specialized Toxicology Support
Bioexcel provides specialized toxicology and biological safety evaluation support for medical device and IVD manufacturers to demonstrate patient safety and regulatory compliance.
Our toxicology services are structured in accordance with the ISO 10993 series, EU MDR Annex I (GSPR), and Notified Body expectations, ensuring that biological safety conclusions are scientifically justified, traceable, and inspection-ready.
We support manufacturers throughout the product lifecycle, from pre-market biological evaluation to postmarket safety updates and remediation of Notified Body findings.
What We Support
- ISO 10993 biological evaluation strategy and planning
- Toxicological Risk Assessment (TRA)
- Extractables & Leachables toxicological evaluation (devices)
- Technical documentation lifecycle management
- Biological safety gap assessments and remediation
Biological Evaluation Plan (BEP)
Development of Biological Evaluation Plans defining the applicable biological endpoints, toxicological considerations, and testing strategies based on device materials, nature of body contact, and clinical use duration, in line with ISO 10993-1.
Toxicological Risk Assessment (TRA)
Systematic evaluation of chemical constituents, exposure scenarios, and toxicological endpoints to assess potential patient risk and support biological safety conclusions. Toxicological Risk Assessments are prepared using a science-based and regulator-accepted approach suitable for regulatory review.
Extractables & Leachables — Toxicological Evaluation (Devices)
Toxicological assessment of extractables and leachables identified from device materials, manufacturing processes, or packaging, including patient exposure estimation and safety margin justification.
Biological Evaluation Report (BER)
Preparation of Biological Evaluation Reports integrating toxicology, biocompatibility data, and risk management conclusions in accordance with ISO 10993 and EU MDR GSPR requirements.
Biological Safety Gap Assessment
Critical review of existing biological and toxicological data to identify gaps against current regulatory expectations, with clear remediation strategies to address Notified Body observations.
Regulatory & Standards Alignment
Toxicology and biological safety services are aligned with: ISO 10993 series (Biological evaluation of medical devices) – EU MDR Annex I – General Safety and Performance Requirements (GSPR) – ISO 14971 risk management integration – Notified Body biological safety review practices.
Integration with Technical & Clinical Documentation
Built for Regulatory Review and Audits — Toxicology outputs are integrated with: Technical & Quality documentation – Risk Management File – Clinical Evaluation Reports (CER) – Post-Market Surveillance activities. This ensures consistency and traceability across the entire regulatory dossier.
- Medical Device manufacturers (Class I, IIa, IIb, III)
- In Vitro Diagnostic (IVD) manufacturers
- QA / RA teams preparing for regulatory submissions or audits
- Companies responding to Notified Body biological safety findings
Demonstrate Biological Safety with Confidence
- Exclusive focus on Medical Devices & IVDs
- ISO 10993 and MDR-aligned toxicology methodology
- Regulator- and Notified Body-focused documentation
- Practical, inspection-ready biological safety conclusions
Toxicology & Biological Safety Evaluation For Medical Devices And IVDs
Toxicological risk assessment and biological safety documentation aligned with ISO 10993, EU MDR, and IVDR requirements.