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.

Bioexcel provides specialized

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

Toxicology Services

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.

Alignment & Documentation

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.

Who This Service Is For

  • 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

Why Bioexcel

  • 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

Demonstrate Biological Safety with Confidence

Bioexcel supports medical device and IVD manufacturers in meeting toxicology and biological safety requirements with scientific rigor and regulatory clarity.