In-Vivo Testing (Implantation & Systemic Toxicity)
In-Vivo testing evaluate the biological response to materials, devices, or coatings within a living system, providing definitive evidence of local tissue compatibility, systemic toxicity, inflammatory response, biodegradation, healing, and long-term integration. These analysis capture complex biological interactions that cannot be fully replicated in vitro, making them essential for implantable, absorbable, and long-term contact products.
At Materials Metric, in-vivo implantation and systemic toxicity studies are designed to align with ISO 10993-6, ISO 10993-11, USP, and FDA expectations, generating clinically relevant safety and performance data that support product development, biological risk assessment, and regulatory submissions.
Uses of In-Vivo Studies
• Assess local tissue compatibility, irritation, fibrosis, or inflammation
• Evaluate systemic toxicity following material exposure
• Examine biodegradation and resorption behavior of absorbable materials
• Validate implant–tissue integration and stability
• Support FDA submissions for implants, resorbables, and long-term devices
• Investigate unexpected responses from earlier in-vitro or chemical tests
Applications
• Orthopedic and dental implants
• Absorbable biomaterials and scaffolds
• Coatings and drug-eluting systems
• Vascular and cardiac devices
• Catheters, sensors, and long-term implants
• Tissue-contacting polymers, hydrogels, elastomers
• Wound healing, regenerative, and reconstructive materials
Sample Analysis Process
1. Study Design
- Selection of implantation site (subcutaneous, intramuscular, bone, vascular, or tissue-specific)
- Determination of exposure duration (acute, sub-chronic, chronic)
- Definition of biological endpoints based on device classification
2. Implantation & Monitoring
- Surgical placement following standardized guidance
- Monitoring for systemic toxicity, behavioral changes, and local reaction
- Collection of tissues, fluids, and organs for analysis
3. Endpoint Evaluations
- Histopathology for inflammation, fibrosis, necrosis, and healing
- Local effects scoring per ISO 10993-6
- Systemic toxicity per ISO 10993-11
- Biodegradation assessment for absorbable devices
- Implant–tissue interface analysis
4. Data Analysis & Reporting
- High-resolution pathology images
- Quantitative scoring of tissue reactions
- Evaluation of systemic organ pathology
- Degradation and absorption profiles
- Full ISO-aligned interpretations and regulatory justification
Why Choose Materials Metric for In-Vivo Studies
Materials Metric provides scientifically rigorous, regulator-aligned in-vivo biocompatibility studies backed by deep expertise in biomaterials, toxicology, and biological safety.
We offer:
• ISO 10993-6 & 10993-11 Compliant Study Designs
Studies structured to meet FDA, EU MDR, PMA, and global regulatory expectations.
• ISO 9001:2015 Accredited Workflows
Every step follows strict quality standards, ensuring reproducibility, traceability, and audit-ready study execution.
• Expert Histopathology & Biological Interpretation
Interpretation from experienced biomaterials scientists who clarify why tissue responses occur—not just what is observed.
• Integrated Chemical + Biological Insight
In-vivo responses are correlated with:
• chemical characterization
• extractables/leachables
• surface chemistry
• microstructure & coatings
• mechanical behavior
This provides a complete understanding of material–tissue interactions.
• Submission-Ready Documentation
Reports formatted for smooth inclusion in 510(k), PMA, De Novo, and ISO 10993 Biological Evaluation Plans.
Materials Metric ensures your in-vivo data is scientifically sound, defensible, and aligned with regulatory pathways, reducing risk and expediting approval.