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
โข Assess local tissue compatibility, irritation, fibrosis, or inflammation
โข Evaluate systemic toxicity following material exposure
โข Examine biodegradation and resorption behavior of absorbable materials
โข Validate implantโtissue integration and stability
โข Support FDA submissions for implants, resorbables, and long-term devices
โข Investigate unexpected responses from earlier in-vitro or chemical tests
Applications
โข Orthopedic and dental implants
โข Absorbable biomaterials and scaffolds
โข Coatings and drug-eluting systems
โข Vascular and cardiac devices
โข Catheters, sensors, and long-term implants
โข Tissue-contacting polymers, hydrogels, elastomers
โข 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
- Implantโtissue 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:
โข ISO 10993-6 & 10993-11 Compliant Study Designs
Studies structured to meet FDA, EU MDR, PMA, and global regulatory expectations.
โข ISO 9001:2015 Accredited Workflows
Every step follows strict quality standards, ensuring reproducibility, traceability, and audit-ready study execution.
โข Expert Histopathology & Biological Interpretation
Interpretation from experienced biomaterials scientists who clarify why tissue responses occurโnot just what is observed.
โข Integrated Chemical + Biological Insight
In-vivo responses are correlated with:
โข chemical characterization
โข extractables/leachables
โข surface chemistry
โข microstructure & coatings
โข mechanical behavior
This provides a complete understanding of materialโtissue interactions.
โข 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.
