Biological Safety Consulting
Biological Safety Consulting provides a structured, science-driven approach to ensuring that materials, devices, and systems are safe for their intended biological use and compliant with global regulatory expectations. This service integrates biological risk assessment, testing strategy development, and regulatory alignment to support ISO 10993 series requirements and FDA guidance.
At Materials Metric, we support biological safety evaluation across polymers, metals, ceramics, coatings, nanomaterials, and tissue-contacting systems by translating material chemistry, exposure conditions, and intended use into clear, defensible biological safety pathways. Our consulting helps clients identify data gaps, minimize unnecessary testing, and generate evidence-based justifications that withstand regulatory review.
Uses
โข Plan ISO 10993 biocompatibility test matrices
โข Identify extractables/leachables requirements
โข Reduce unnecessary biological testing
โข Develop chemical characterization strategies
โข Assess toxicological and biological risk
Applications
โข Medical devices
โข Biomaterials & implants
โข Drug-device combination products
โข Tissue engineering scaffolds
Consulting Process
1. Biological Risk Assessment
- Exposure route & duration
- Toxicological hazard identification
2. Gap Analysis
- Identify missing ISO 10993 endpoints
3. Test Strategy Development
- Chemical, biological & mechanical considerations
4. Regulatory Support
- Rationales for test omission or modification
Why Choose Materials Metric
Materials Metric delivers high-level biological safety guidance grounded in materials science, toxicology, and FDA expectations.
We offer:
โข ISO 9001:2015 governed risk assessment
โข Expertise across the full ISO 10993 series
โข Strong toxicological interpretation
โข Integrated chemical, mechanical, and biological data
โข Clear scientific documentation for regulators
Your biological safety plan will be rigorous, efficient, and scientifically justified.
